Features, Advantages, and Bene�ts

DS-H7546-01 06/18

Features

Patented antibody with high specificity for HbA1c

Fully Automated

Direct measurement of HbA1c

Does not require a standalone system

NGSP Certification & Traceable to IFCC Standard

Advantages

Minimizes cross-reactivity from hemoglobin variant molecules

No offline sample pretreatment

Does not require additional channel for determination of

total hemoglobin

Eliminates the need for HbA1c specific analyzers

Standardized tests results to test methods used in clinical studies

Benefits

More precise results » no interference from hemoglobin variants / adducts; Carbamylated Hb, Acetylated Hb, HbA2, HbS, HbC, HbE and HbD

Streamline testing process with more accurate results and less

hands-on activities

Saves space on analyzer and cost of running additional test

Save laboratory space and money by the consolidation of clinical

laboratory equipment

Increase patient confidence by a NGSP certified test

Ordering Information

Product Number Analyzer Speci�c Description

H7546-40 Open Channel R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL

REAGENTS

H7541-CALCALIBRATORS

H7546-120 Open Channel R1: 1 x 90 mL, R2: 1 x 30 mL

OH546-40 Beckman AU R1: 2 x 15 mL, R2: 1 x 10 mL

HBA-480 BS-480 R1: 2 x 60 mL, R2: 2 x 20 mL

HBA-600 BS-200 R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL

12-H7546-40 BS-200(International)R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL

H7541-CTLCONTROLS

Lyophilized

Lyophilized

1 vial each of 4 levels

2 vials each of 2 levels

Instrument Applications

• Abbot Aeroset• Alycon• ATAC 8000 • Beckman/Olympus AU400, AU640, AU2700, AU5400, CX, DxC, LX • Bayer Advia 1650, 1800, 2400• Biolis 24i• Biotecnica BT2000/3000• Chemwell• Cobas 6000, c501, Mira, Mira Plus• Envoy 500• Express• Dimension

• Hitachi - 704, 717, 747, 902, 911, 912, 914, 917• Konelab 20, 30, 60• Mindray - BS-200, BS-300, BS-400, BS-480, BA-800M • Pentra 400• Pointe 360• Prestige 24i• RA - 500, 1000• Randox Daytona• Selectra SE• Sirrus• Spectrum• Targa • Vitros 5

Product Data Sheet 17

Over the past 5 years, incidences pertaining to blood disorders have drastically increased. In the US alone one person is diagnosed with bloodcancer every 3 minutes. An estimated combined total of 174,250 people in the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2018.¹ The breakdown in percentages is shown in figure 1.

Product

The BC-3600 3-Part Differential Automated Hematology Analyzer can process up to 60 samples/ hr. and can accommodate a sample volume as low as 33 µL, allowing it to be a key solution for draw-sensitive patients. It comes equipped with a large touchscreen monitor and intuitive software, enhancing efficiency and productivity for the operator.

Regulatory and Certification

• 510(k) Cleared

Market: Hematology Testing

MedTest Dx 3-Part Differential Automated Hematology AnalyzerAllowing healthcare professionals to address common blood disorders more efficiently

Figure 1:

Estimated cases of common blood disorders in 2018

800.445.9853(International) +1.734.487.8300 www.medtestdx.com

1Seer.cancer.gov. (2018). Surveillance, Epidemiology, and End ResultsProgram. https://seer.cancer.gov/ [Accessed 6 Jul. 2018].

Features, Advantages, and Benefits

DS-M1113-01 07/18

Features

MTFB: 6.6 years

Cyanide Free Reagents

Closed Mode

Multitude of different sample adapters

5 minutes daily maintenance

Advantages

Obtain a robust system that ismanufactured with high

quality components

Non-Toxic

Safer for the operator

Offers flexibility for testing

Minimal maintenance procedure

Benefits

Get the highest percent ROIon your purchase

Environmentally Friendly

Minimize biohazard exposure and time saving

Aid in clinical diagnosis

Shorten morning startup time

Product Number Item Description

3007E-PA0001 BC-3600 Analyzer 1 Analyzer

SCCAL2US SC-CAL Plus Calibrator 2 x 3 mL

BC3D02US BC-3D Control 6 x 3 mL

105-005406-00 M-30D Diluent 20 L/ Tank

105-005405-01 M-30D Diluent 2 x 5.5 L/ Tank

105-005408-00 M-30FCL Lyse 500 mL

ORDERING INFORMATION

Touch button maintenance

USB QC referencerange upload

12 QC files

Simple operation

Eliminate manual entry of QC range

Able to store one full year of QC lot record

Free up operator to perform other duties

Ensure QC range accuracy

No need to delete QC files during the calendar year

105-007828-00 M-30P Probe Cleaner 6 x 17 mL

Predilute ModeCBC with Diff testing can be done

with minimal quantity of blood sample

Ensure testing still available for difficult draw patients such as

pediatric, oncology and geriatric patients

105-005400-00 M-30R Rinse 2 x 5.5L/Tank

105-005399-00 M-30R Rinse 20 L/ Tank

0683-00-0505-02 Thermal Paper 12 Rolls

Product Data Sheet 23

As shown in figure 1, diabetes on a global basis is increasing at an exponential rate. To diagnose and monitor diabetes it is necessary to evaluate patient’s glucose and HbA1c levels. Glucose levels reflect an individual’s glycemia at a specific point in time, whereas HbA1c levels reflect the average glucose levels over the previous 2-3 months. Therefore, HbA1c has been recommended for the diagnosis of diabetes.

Product

The Pointe Scientific two-part HbA1c assay is a stabilized modification of the previous, innovative HbA1c three-part reagent that was first introduced in 2003. The improved reagent maintains the same antibodies and buffers but includes additional stabilizers in the R2 to allow it to become a single component as opposed to two separate components that required mixing prior to use.

Regulatory and Certification

• 510(k) Cleared• CE Mark• NGSP Certified• Referenced to IFCC Standard• Health Canada Medical Device Licensed

Market: Diabetes Testing

Pointe Scientific Hemoglobin A1c Assay:Streamlining diabetes testing with a 2-part HbA1c assay

Figure 1:Diabetes population per IDF diabetes Atlas Eighth Edition 2017

800.445.9853(International) +1.734.487.8300 www.medtestdx.com

Features Advantages

MTBF: 6.6 years Obtain a robust system that is

manufactured with high quality components

Obtain the highest percent ROI on

Large 10.7 Color Touch Screen

CBC with Diff result & Histogram at a glance

No need to scroll up and down the

Closed Mode Safer for the operator Minimize biohazard exposure and

Multitude of sample adaptors Offers flexibility for testing

5 minutes daily maintenance Minimal maintenance procedure Shorten morning startup time

Touch button maintenance Simple operation

Free up operator to perform other

USB QC reference range

upload Eliminate manual entry of QC range Ensure QC

12 QC files Able to store one full year of QC lot record No need to delete QC files during the

40,000 results storage including

histograms

Huge memory among same class of analyzers Plenty of result patient result storage

4 built-in USB ports (1 in front,

3 in back) Convenience access

Enables USB driver, barcode scanner, external keyboard & Mouse

Predilute Mode CBC with Diff testing can be done with minimal quantity of blood sample

Ensure testing still available difficult draw patients such as

pediatric, oncology and geriatric

Cyanide Free Reagents Non-Toxic Environmentally Friendly

DS-M1113-01 frontDS-M1113-01 back