PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25...
Transcript of PROGRAM 2: CHEMISTRY PARAMETERS Order information Notes€¦ · 10 040 021 R1 5 x 20 ml + R2 1 x 25...
845 4201 704
July 2001/2
HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS
TEST ALP ASSAY CODE 5 – 19 - 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 280 – 50 - 0 R2 VOLUME (µl) 70 – 20 - 0 WAVELENGTH (nm) 660 - 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 0 STD. 2 CONC.-POS. 0 – 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 10000 - 0 PROZONE LIMIT 0 EXPECTED VALUE 0 - 258 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
ALKALINE PHOSPHATASE FS DGKC Order information Cat. No. Kit size 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml
10 040 022 R1 5 x 80 ml + R2 1 x 100 ml
10 040 023 R1 1 x 800 ml + R2 1 x 200 ml
10 040 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for
Alkaline phosphatase DGKC FS for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany
845 1200 704
July 2001/2
HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS
TEST CL ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 –20 – NO WAVELENGTH (nm) 600 – 480 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MMOL/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 95 – 105 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CHLORIDE FS Order information Cat. No. Kit size 10 120 021 R 5 x 25 ml + 1 x 3 ml Std
1 1200 99 10 026 R 6 x 100 ml
10 120 023 R 1 x 1000 ml
10 120 0030 6 x 3 ml Standard
10 120 704 R 8 x 50 ml Notes 1. Please refer to the package insert for Chloride FS for
detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany
845 1200 704
July 2001/2
845 2521 704
July 2001/2
HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS
TEST GLUC ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 70 – 115 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
GLUCOSE HEXOKINASE FS Order information Cat. No. Kit size 10 251 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std
1 2511 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml
10 251 023 R1 1 x 800 ml + R2 1 x 200 ml
10 250 030 6 x 3 ml Standard
10 251 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for Glucose Hexokinase FS
for detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany
845 2521 704
July 2001/2
845 3001 704
July 2001/2
HITACHI 704 Chemistry settings Temperature: 37 °C PROGRAM 2: CHEMISTRY PARAMETERS
TEST UA ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 2.3 – 8.2 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
URIC ACID FS TOOS Order information Cat. No. Kit size 10 300 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml Std
1 3001 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml
10 300 023 R1 1 x 800 ml + R2 1 x 200 ml
10 300 030 6 x 3 ml Standard
10 300 704 R1 8 x 50 ml + R2 8 x 12.5 ml Notes 1. Please refer to the package insert for Uric Acid FS TOOS for
detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany
845 3001 704
July 2001/2
845 3021 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST UA ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT mg/dl SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 2.3 – 8.2 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
URIC ACID FS TBHBA Order information
Cat. No. 1 3021 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0220 10 02 01
September 2006/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST ALB ASSAY CODE 1 – 7 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * – 2 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT G / DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 3.5 – 5.2 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
ALBUMIN FS Order information
Cat. No. 1 0220 .. .. …
Notes
1. Please refer to the package insert for Albumin FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0501 10 02 01
March 2007/5
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST AMYL ASSAY CODE 5 – 25 - 31 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 280 – 50 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 660 – 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 11000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # - # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
-AMYLASE CC FS
Order information
Cat. No. 1 0501 .. .. …
Notes
1. Please refer to the package insert for -Amylase CC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 7102 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST APOA ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 20 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 0 – 570 CALIBR. METHOD 3 – 1 – 4 STD. 1 CONC.-POS. 0 - 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * - * STD. 4 CONC.-POS. * - * STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 - 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 110 - 190 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
APOLIPOPROTEIN A1 FS Order information
Cat. No. 1 7102 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein A1 FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 7112 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST APOB ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 20 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 0 – 340 CALIBR. METHOD 3 – 1 – 4 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * - * STD. 4 CONC.-POS. * - * STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 - 0 UNIT MG/DL SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 75 – 155 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
APOLIPOPROTEIN B FS Order information
Cat. No. 1 7112 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein B FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
846 0950 10 02 01
September 2006/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CO2 ASSAY CODE 2 – 4 – 25 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 505 – 415 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MMOL/L SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 1 PROZONE LIMIT -32000 – 0 EXPECTED VALUE 22 – 29 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
BICARBONATE FS Order information
Cat. No. 1 0950 .. .. …
Notes
1. Please refer to the package insert for Bicarbonate FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 3 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0821 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST BIDI ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 320 – 50 – 0 R2 VOLUME (µl) 80 – 20 – 0 WAVELENGTH (nm) 660 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 0.0 – 0.2 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
BILIRUBIN AUTO DIRECT FS
Order information
Cat. No. 1 0821 .. .. …
Notes
1. Please refer to the package insert for Bilirubin Auto Direct FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0811 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST BILI ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 320 – 50 – 0 R2 VOLUME (µl) 80 – 20 – 0 WAVELENGTH (nm) 660 - 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 - 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 0.1 – 1.2 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
BILIRUBIN AUTO TOTAL FS
Order information
Cat. No. 1 0811 .. .. …
Notes
1. Please refer to the package insert for Bilirubin Auto Total FS
for detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
846 1130 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CALC ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 700 – 660 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 8.6 – 10.3 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CALCIUM AS FS Order information
Cat. No. 1 1130 .. .. …
Notes
1. Please refer to the package insert for Calcium AS FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1651 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CKMB ASSAY CODE 5 – 25 – 32 SAMPLE VOLUME (µl) 13 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 9000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 24 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
CK-MB FS Order information
Cat. No. 1 1651 .. .. …
Notes
1. Please refer to the package insert for CK-MB FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1601 10 02 01
April 2003/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CK ASSAY CODE 5 – 22 – 32 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 9000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
CK-NAC FS Order information
Cat. No. 1 1601 .. .. …
Notes
1. Please refer to the package insert for CK-NAC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1200 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CL ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 –20 – NO WAVELENGTH (nm) 600 – 480 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MMOL/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 95 – 105 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CHLORIDE FS Order information
Cat. No. 1 1200 .. .. …
Notes
1. Please refer to the package insert for Chloride FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 7 days
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1300 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CHOL ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 200 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CHOLESTEROL FS Order information
Cat. No. 1 1300 .. .. …
Notes
1. Please refer to the package insert for Cholesterol FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1401 10 02 01
September 2006/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CHE ASSAY CODE 5 – 21 – 30 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 300 – 50 – NO R2 VOLUME (µl) 75 – 20 – NO WAVELENGTH (nm) – 415 CALIBR. METHOD 2** – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE 3930 – 11500 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
CHOLINESTERASE FS Order information
Cat. No. 1 1401 .. .. …
Notes
1. Please refer to the package insert for Cholinesterase FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 8 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1711 10 02 01
March 2008/5
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CREA ASSAY CODE 5 – 19 – 23 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 570 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 5500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CREATININE FS Order information
Cat. No. 1 1711 .. .. …
Notes
1. Please refer to the package insert for Creatinine FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser 4 days
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1711 10 02 01
March 2008/5
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CREA ASSAY CODE 5 – 19 – 23 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 570 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 5500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0.6 – 1.3 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CREATININE FS
Compensated Method
To use the Creatinine Compensated Method on the Hitachi 704 go to Parameter Job, Chapter 7, Compensated Test and input the following formula; When the units are mg/dL [ (Crea test Code) ] [ - ] [ 0.3 ] [ ; ] When the units are µmol/L [ (Crea test Code) ] [ - ] [ 27 ] [ ; ] Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected
845 1759 10 02 53October 2008/3
COBAS MIRA Plus
Instrument settingsTest name:CREATemperature: 37 °C
GENERALMEASUREMENT MODE: ABSORB [1]REACTION MODE: R –S – SR1 [3]CALIBRATION MODE: SLOPE AVG [2]REAGENT BLANK: REAG / DIL [2]CLEANER: NO [1]WAVELENGTH: 550 nm [4]DECIMAL POSITION: 21UNIT: 12 (mg/ dl) or 04 (µmol/l)
ANALYSISPOST DIL. FACTOR: [2]CONC. FACTOR: NO [SPACE]SAMPLE CYCLE: [1]VOLUME: 6 µlDILUTION NAME: H2O [00]
VOLUME: 10 µlREAGENT CYCLE: 1VOLUME: 150 µlSTART R 1 CYCLE: 10VOLUME: 75 µlDILUTION NAME: [00]VOLUME: 10 µl
CALCULATIONSAMPLE LIMIT: NO [SPACE]POINT:REAC. DIRECTION: INCREASE [1]CHECK: ON [1]CONVERS. FACTOR: 1OFFSET: 0TEST RANGE LOW: 0 (mg/dl) or 0 (µmol/l)
HIGH: 17.3 (mg/dl) or 1500 (µmol/l)NORM. RANGE LOW: 0.5 (mg/dl) or 44 (µmol/l)
HIGH: 1.1 (mg/dl) or 97 (µmol/l)NUMBER OF STEPS: 1CALC. STEP A: ENDPOINT [1]READINGS FIRST: 11
LAST: 25REACTION LIMIT:POINT:
CALIBRATIONCALIBRATION INTERVAL: EACH DAY [2]TIME: NO [SPACE]BLANK:REAG. RANGE LOW: NO [SPACE]
HIGH: NO [SPACE]BLANK RANGE LOW: NO [SPACE]
HIGH: NO [SPACE]FACTOR:
STANDARD POS: # .....STD.-1: Calibrator value *....STD.-2: NO [SPACE]STD.-3: NO [SPACE]
REPLICATE: DUPL [1]DEVIATION: 10%
CONTROLCS 1 POS: Low:..... Assign:.... High:........CS 2 POS: Low:..... Assign:.... High:........CS 3 POS Low:..... Assign:.... High:........#) Data entry by the user*) Enter calibration or standard value and position**) The factor must be checked by a calibration serum.
CREATININE PAP FS
Order information
Cat. No. 1 1759 .. .. …
Notes
1. Please refer to the package insert for Creatinine PAP FS fordetailed information about the test on the following:
Clinical RelevanceMethod and PrincipleComposition and Stability of the ReagentsSpecimensCalibrators and ControlsPerformance Characteristics regarding
- Measuring Range- Specificity/Interferences- Sensitivity/Limit of Detection- Precision (Reproducibility, Repeatability)- Method Comparison
Reference RangesLiterature
2. The stability of the reagent on board the analyser is at least onemonth provided that contamination and evaporation are avoided.
3. Manufactured byDiaSys Diagnostic Systems GmbHAlte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoidmisinterpretation measured results have to be validated andassessed with caution
845 7059 10 02 01
April 2004/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST FERR ASSAY CODE 2 – 18 – 32 SAMPLE VOLUME (µl) 12 R1 VOLUME (µl) 240 – 20 – NO R2 VOLUME (µl) 120 – 20 – NO WAVELENGTH (nm) – 570 CALIBR. METHOD 3 – 4 – 5 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. 0 – 0 UNIT µG/L SD LIMIT 999 DUPLICATE LIMIT 32000 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT -32000 – 0 EXPECTED VALUE 30 – 300 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
FERRITIN FS Order information Cat. No. 1 7059 .. .. …
Notes
1. Please refer to the package insert for Ferritin FS for
detailed information about the test on the following
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 1911 10 02 01
September 2006/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST FE ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT UG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 23 – 168 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
IRON FS Ferene Order information
Cat. No. 1 1911 .. .. …
Notes
1. Please refer to the package insert for Iron FS Ferene for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0411 10 02 01
September 2006/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST ALP ASSAY CODE 5 – 19 - 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 280 – 50 – 0 R2 VOLUME (µl) 70 – 20 – 0 WAVELENGTH (nm) 660 - 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 0 STD. 2 CONC.-POS. 0 – 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/l SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 12000 – 0 PROZONE LIMIT 0 EXPECTED VALUE # - # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
ALKALINE PHOSPHATASE FS IFCC 37° C
Order information
Cat. No. 1 0441 .. .. …
Notes
1. Please refer to the package insert for
Alkaline phosphatase IFCC FS for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 8 days
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 5211 10 02 01
January 2005/2
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST PHOS ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 0 – 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 1.8 – 4.5 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
PHOSPHATE FS Order information
Cat. No. 1 5211 .. .. …
Notes
1. Please refer to the package insert for Phosphate FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
845 2801 10 02 01
April 2003/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST GGT ASSAY CODE 5 – 19 – 32 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 660 – 415 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 5500 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
GAMMA GT FS (Szasz mod.) Order information
Cat. No. 1 2801 .. .. …
Notes
1. Please refer to the package insert for Gamma-GT FS (Szasz
mod.) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 2500 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST GLUC ASSAY CODE 1 – 32 - 0 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 – 50 - NO R2 VOLUME (µl) 0 – 20 - NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE 70 - 115 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
GLUCOSE GOD FS Order information
Cat. No. 1 2500 .. .. …
Notes
1. Please refer to the package insert for Glucose GOD FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 3329 10 02 01
January 2010/5
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST HbA1c ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 240 – 20 – 0 R2 VOLUME (µl) 120 – 20 – 0 WAVELENGTH (nm) 0 - 660 CALIBR. METHOD 3 – 4 – 5** STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * – * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. 0 – 0 UNIT # SD LIMIT 999 DUPLICATE LIMIT 10000 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 32000 - 0 PROZONE LIMIT -32000 - 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position **) Spline function
oneHbA1c FS Order information
Cat. No. 1 3329 .. .. …
Notes
1. Please refer to the package insert for oneHbA1c FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
30 days provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 3521 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST HDL ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 35 – 80 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
HDL-C IMMUNO FS Order information
Cat. No. 1 3521 .. .. …
Notes
1. Please refer to the package insert for HDL-C Immuno FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 4001 10 02 01
September 2006/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST LAC ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320 – 50 – 0 R2 VOLUME (µl) 80 – 20 – 0 WAVELENGTH (nm) 700 - 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 - 0 PROZONE LIMIT 0 - 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
LACTATE FS Order information
Cat. No. 1 4001 .. .. …
Notes
1. Please refer to the package insert for Lactate FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 5 days
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 4201 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST LDH ASSAY CODE 5 – 19 – 28 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6500 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE 225 – 480 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
LDH FS DGKC
Order information
Cat. No. 1 4201 .. .. …
Notes
1. Please refer to the package insert for LDH DGKC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 4121 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST LDL ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 320 – 20 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 130 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
LDL-C SELECT FS Order information
Cat. No. 1 4121 .. .. …
Notes
1. Please refer to the package insert for LDL-C Select FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 4321 10 02 01 September 2006/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST LIP ASSAY CODE 5 – 21 – 25 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 700 – 570 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - 2 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 32000 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 60 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
LIPASE DC FS Order information
Cat. No. 1 4321 .. .. …
Notes
1. Please refer to the package insert for Lipase DC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 7139 10 02 01
August 2007/2
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST LPA ASSAY CODE 2 – 19 – 31 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 240 – 20 – NO R2 VOLUME (µl) 120 – 20 – NO WAVELENGTH (nm) 0 – 700 CALIBR. METHOD 3 – 1 – 4 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. * – * UNIT MG/DL SD LIMIT 999 DUPLICATE LIMIT 1000 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 30 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
Lp(a) 21 FS
Order information
Cat. No. 1 7139 .. .. …
Notes
1. Please refer to the package insert for Lp(a) 21 FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 3 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 4610 10 02 01
September 2006/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST MAG ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 50 – NO WAVELENGTH (nm) 700 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - 2 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 1.8 – 2.6 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
MAGNESIUM XL FS Order information
Cat. No. 1 4610 .. .. …
Notes
1. Please refer to the package insert for Magnesium XL FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 3 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 7045 10 02 01
November 2008/1
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST CRP ASSAY CODE 2 – 18 – 32 SAMPLE VOLUME (µl) 18 R1 VOLUME (µl) 180 – 20 – NO R2 VOLUME (µl) 180 – 20 – NO WAVELENGTH (nm) – 505 CALIBR. METHOD 3 – 1 – 6 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. * – * STD. 4 CONC.-POS. * – * STD. 5 CONC.-POS. * – * STD. 6 CONC.-POS. * – * UNIT mg/L SD LIMIT 999 DUPLICATE LIMIT 500 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE 0 – 5 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
CRP U-hs High sensitive (hs) application
Order information Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs for detailed
information about the test on the following
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 2311 10 02 01
September 2006/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST TP ASSAY CODE 2 – 15 – 32 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 320 – 50 – NO R2 VOLUME (µl) 80 – 20 – NO WAVELENGTH (nm) 0 – 546 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0.0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT G/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 6.6 – 8.8 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
TOTAL PROTEIN FS Order information
Cat. No. 1 2311 .. .. …
Notes
1. Please refer to the package insert for Total Protein FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 10 days
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 0210 10 52 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST TPU ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 6 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 700 – 600 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/L SD LIMIT 0.1 DUPLICATE LIMIT 200 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 32000 – 1 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
TOTAL PROTEIN UC FS Order information
Cat. No. 1 0210 .. .. …
Notes
1. Please refer to the package insert for Total Protein UC FS
for detailed information about the test on the following
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 2601 10 02 01
April 2003/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST GOT ASSAY CODE 5 – 20 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
ASAT(GOT) FS (IFCC mod.)
Order information
Cat. No. 1 2601 .. .. …
Notes
1. Please refer to the package insert for
ASAT(GOT) FS (IFCC Mod) for the detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 2701 10 02 01
April 2003/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST GPT ASSAY CODE 5 – 20 – 32 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD **2 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. 0 - 0 STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT U/L SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE # – # INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
**) Factor must be checked by a calibration serum
ALAT(GPT) FS (IFCC mod.)
Order information
Cat. No. 1 2701 .. .. …
Notes
1. Please refer to the package insert for ALAT(GPT) FS (IFCC Mod.)
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 5710 10 02 01
July 2001/3
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST TRIG ASSAY CODE 1 – 32 – 0 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350 – 50 – NO R2 VOLUME (µl) 0 – 20 – NO WAVELENGTH (nm) 700 – 505 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 0 – 0 PROZONE LIMIT 0 – 0 EXPECTED VALUE 0 – 200 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
TRIGLYCERIDES FS Order information
Cat. No. 1 5710 .. .. …
Notes
1. Please refer to the package insert for Triglycerides FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at least
one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
845 3101 10 02 01
September 2006/4
HITACHI 704 Chemistry settings Temperature: 37 °C
PROGRAM 2: CHEMISTRY PARAMETERS
TEST UREA ASSAY CODE 5 – 19 – 22 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 280 – 50 – NO R2 VOLUME (µl) 70 – 20 – NO WAVELENGTH (nm) 376 – 340 CALIBR. METHOD 1 – 0 – 0 STD. 1 CONC.-POS. 0 – 1 STD. 2 CONC.-POS. * - * STD. 3 CONC.-POS. 0 – 0 STD. 4 CONC.-POS. 0 – 0 STD. 5 CONC.-POS. 0 – 0 STD. 6 CONC.-POS. 0 – 0 UNIT MG/DL SD LIMIT 0.1 DUPLICATE LIMIT 100 SENSITIVITY LIMIT 0 ABS. LIMIT (INC/DEC) 6000 – 1 PROZONE LIMIT 0 – 0 EXPECTED VALUE 17 – 43 INSTRUMENT FACTOR 1.0
#) Data entry by the user *) Enter calibration or standard value and position
UREA FS Order information
Cat. No. 1 3101 .. .. …
Notes
1. Please refer to the package insert for Urea FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is 6 weeks
provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.