Ih general catalogue

IMMUNOHEMATOLOGYGENERAL CATALOGUEREAGENTS INSTRUMENTATION HEMOVIGILANCE

88888 8Reagents ................................................... 4

DG Gel® .............................................. 5

DG Red Line ..................................... 15

DG Hemotype ................................... 23

Auxiliary reagents & solutions ............ 25

Instrumentation ...................................... 26

Fully automated

WADiana® Compact ................... 28

Semiautomated

Diana Processor ......................... 30

Diana Reader ............................. 30

Manual

DG Therm .................................. 31

DG Spin ..................................... 32

Auxiliary accessories

DG Rack .................................... 33

DG Stepper ................................. 33

DG Dispenser ............................ 33

Hemovigilance ........................................ 34

Gricode® .......................................... 36

Blue ................................................. 37

888 Grifols, a company dedicated to the development and advancement of Transfusion Medicine since 1940, designs and manufactures reagents, instrumentation and software totally adapted to the new trends in Immunohematology Laboratories.

At Grifols, we believe it is our responsibility to continually improve upon our products to fully provide all the necessary tools to our customers. Today, an integrated system is vital for immunohematology labs to provide the highest level of safety in blood transfusion.

Simplification through eliminating needless tests, flexibility in reagents and instrumentation, maximum cost-efficiency and the implementation of hemovigilance tools are the main policies in today’s transfusion services.

This catalogue contains Grifols’ line of Immunohematology products including reagents, instrumentation and hemovigilance tools, which play an active role in ensuring the safety of the transfusion chain.

Grifols has created Move to 8! to fully inform all professionals involved in transfusion medicine of the safety and efficiency of our products.

Move to 8!Move to Grifols.

Move to 8!

8

REAGENTSREAGENTS

DG Gel®

DG Red Line

DG Hemotype

Auxiliary reagents

REAGENTS IMMUNOHEMATOLOGY GENERAL CATALOGUE 5

The New Standard in the Column Agglutination Technique

8-column gel card based on the column agglutination technique for blood typing and investigation of unexpected antibodies.

Grifols Clear Card Technology

The Clear Card Technology is the culmination of Grifols’ years of experience in the field of immunohematology. By carefully selecting and treating raw materials we have developed a uniform, homogenous and consistent gel with exceptional clarity.

The combination of a high-definition gel and the new design of the reaction column gives the laboratory technician clear results.

Grifols Clear Card Technology is not only a gel treatment technique, but also a new concept for a new product: DG Gel®, a new standard in the column agglutination technique.

DG Gel®

Grifols DG Gel®

Reference Product Presentation210310 DG Gel® ABO/Rh 4 x 12 cards210311 DG Gel® ABO/Rh (2D) 4 x 12 cards210313 DG Gel® ABO-CDE 4 x 12 cards210312 DG Gel® Confirm 4 x 12 cards210314 DG Gel® Anti-D 1 x 12 cards210315 DG Gel® Rh 4 x 12 cards210316 Dg Gel® Rh+Kell 4 x 12 cards210324 DG Gel® AB (x4) 4 x 12 cards210319 DG Gel® Coombs 4 x 12 cards210320 DG Gel® Neutral 4 x 12 cards210321 DG Gel® Neutral/Coombs 4 x 12 cards210318 DG Gel® CT 4 x 12 cards210322 DG Gel® Anti-IgG 4 x 12 cards210317 DG Gel® Neonatal 4 x 12 cards210323 DG Gel® DC Scan 1 x 12 cards

6

Grifols DG Gel®

IMMUNOHEMATOLOGY GENERAL CATALOGUE REAGENTS

DG Gel® ABO/Rh Ref. 210310

Technique: Determination of the antigens of the ABO and Rh (D) systems and determination of the reverse ABO group.

Number of tests/card: 1

Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones16243 G2 and 16247 E6)Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)Anti-AB: monoclonal anti-AB (mixture of IgM antibodies of murine origin, clones16245 F11 D8, 16247 E6 and 7821 D9)Anti-D: monoclonal anti-D (IgM antibodies of human origin, clone P3x61)Anti-CDE: monoclonal anti-CDE (mixture of IgM antibodies of human origin, clonesP3x61, P3x25513 G8, P3x234)Ctl. : buffered solution without antibodies (control microtube)N: buffered solution without antibodies (reverse group test)

Storage: 2-25 ºC

Presentation: 4 x 12 cards

DG Gel® ABO/CDE Ref. 210313

Technique: Determination of the antigens of the ABO and Rh (D, C, E) systems and determination of the reverse ABO group.


Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones 16243 G2 and 16247 E6)Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)Anti-D: monoclonal anti-D (IgM antibodies of human origin, clone P3x61)Anti-C: monoclonal anti-C (IgM antibodies of human origin, clone P3x25513 G8)Anti-E: monoclonal anti-E (IgM antibodies of human origin, clone 906)Ctl. : buffered solution without antibodies (control microtube)N: buffered solution without antibodies (reverse group test)

Storage: 2-25 ºC


A B AB D CDE Ctl N/A1 N/B

A B D C E Ctl N/A1 N/B

Grifols DG Gel®


DG Gel® ABO/Rh (2D) Ref. 210311

Technique: Determination of the antigens of the ABO and Rh (D) system and determination of the reverse ABO group.


Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones 16243 G2 and 16247 E6)Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)Anti-AB: monoclonal anti-AB (mixture of IgM antibodies of murine origin, clones 16245 F11 D8, 16247 E6 and 7821 D9)Anti-D: monoclonal anti-D (IgM antibodies of human origin, clone P3x61)Anti-D’: monoclonal anti-D (mixture of IgG and IgM antibodies of human origin, clones P3x290, P3x35, P3x61 and P3x21223 B10) (This anti-D monoclonal reagent detects weak D and partial variants of the D antigen, including the DVI variant)Ctl.: buffered solution without antibodies (control microtube)N: buffered solution without antibodies (reverse group test)

Storage: 2-8 ºC


DG Gel® Confirm Ref. 210312

Technique: Confirmation of the blood groups of the ABO and Rh (D) system.


Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones 16243 G2 and 16247 E6)Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)Anti-D: monoclonal anti-D (mixture of IgG and IgM antibodies of human origin, clones P3x290, P3x35, P3x61 and P3x21223 B10) (This anti-D monoclonal reagent detects weak D and partial variants of the D antigen, including the DVI variant)Ctl.: buffered solution without antibodies (control microtube)

Storage: 2-8 ºC


A B AB D D’ Ctrl N/A1 N/B

A B D Ctl A B D Ctl

8

Grifols DG Gel®


DG Gel® Anti-D Ref. 210314

Technique: Determination of the Rh (D).


Clones:Anti-D: monoclonal anti-D (mixture of IgG and IgM antibodies of human origin, clones P3x290, P3x35, P3x61 and P3x21223 B10) (This anti-D monoclonal reagent detects weak D and partial variants of the D antigen, including the DVI variant)Ctl.: buffered solution without antibodies (control microtube)

Storage: 2-8 ºC


DG Gel® Rh Ref. 210315

Technique: Determination of the antigens of the Rh system.


Clones:Anti-C: monoclonal anti-C (IgM antibodies of human origin, clone P3x25513 G8)Anti-c: monoclonal anti-c (IgM antibodies of human origin, clone MS 33)Anti-E: monoclonal anti-E (IgM antibodies of human origin, clone 906)Anti-e: monoclonal anti-e (mixture of IgM antibodies of human origin, clones MS 16 and MS 63)

Storage: 2-25 ºC


C c E e C c E e

D Ctl D Ctl D Ctl D Ctl

Grifols DG Gel®


DG Gel® Rh + Kell Ref. 210316

Technique: Determination of the antigens of the Rh and Kell system.


Clones:Anti-D: monoclonal anti-D (mixture of IgG and IgM antibodies of human origin, clones P3x290, P3x35, P3x61, P3x21223 B10) (This anti-D monoclonal reagent detects weak D and partial variants of the D antigen, including the DVI variant)Anti-C: monoclonal anti-C (IgM antibodies of human origin, clone P3x25513 G8)Anti-Cw: monoclonal anti-Cw (IgM antibodies of human origin, clone MS 110) Anti-c: monoclonal anti-c (IgM antibodies of human origin, clone MS 33)Anti-E: monoclonal anti-E (IgM antibodies of human origin, clone 906)Anti-e: monoclonal anti-e (mixture of IgM antibodies of human origin, clones MS 16 and MS 63) Anti-Kell: monoclonal anti-Kell (IgM antibodies of human origin, clone MS 56)Ctl.: buffered solution without antibodies (control microtube)

Storage: 2-8 ºC


DG Gel® AB (x4) Ref. 210324

Technique: Confirmation of the blood groups of the ABO system.


Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones 16243 G2 and 16247 E6Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)

Storage: 2-25 ºC


D C Cw c E e Kell Ctl

A B A B A B A B

10

Grifols DG Gel®


DG Gel® Coombs Ref. 210319

Technique: Indirect Coombs and Direct Coombs tests. The Indirect Coombs tests include screening and identification of unexpected antibodies, crossmatch tests, autocontrol and red blood cell typing.

Number of tests/card: depending on the test

Clones:AHG: Coombs, buffered low ionic strength solution (LISS) with polyspecific anti-human globulin. Mixture of rabbit polyclonal anti-IgG and monoclonal anti-C3d antibodies, IgM antibodies of murine origin, clone 12011 D10

Storage: 2-25 ºC


DG Gel® Neutral Ref. 210320

Technique: Physical medium for saline and enzymatic tests. The saline and enzymatic technique tests include: screening and identification of unexpected antibodies, crossmatch tests, autocontrol, red blood cell typing and determination of the reverse ABO group.


Clones:N: buffered solution without antibodies (neutral microtubes)

Storage: 2-25 ºC


AHG AHG AHG AHG AHG AHG AHG AHG

N N N N N N N N

Grifols DG Gel®


DG Gel® Neutral/Coombs Ref. 210321

Technique: Indirect, Direct Coombs tests and physical medium for saline and enzymatic tests. The tests include: screening and identification of unexpected antibodies, crossmatch tests, autocontrol and red blood cell typing.


Clones:N: buffered solution without antibodies (neutral microtube).AHG: Coombs, buffered low ionic strength solution (LISS) with polyspecific anti-human globulin. Mixture of rabbit polyclonal anti-IgG and monoclonal anti-C3d antibodies, IgM antibodies of murine origin, clone 12011 D10

Storage: 2-25 ºC


DG Gel® Anti-IgG Ref. 210322

Technique: Indirect Coombs and Direct Coombs tests. The Indirect Coombs tests include: screening and identification of unexpected antibodies, crossmatch tests and autocontrol.


Clones: IgG: Anti-IgG (rabbit polyclonal) in low ionic strength solution (LISS)

Storage: 2-25 ºC


N N N N AHG AHG AHG AHG

IgG IgG IgG IgG IgG IgG IgG IgG

12

Grifols DG Gel®


DG Gel® Neonatal Ref. 210317

Technique: Determination of the antigens of the ABO and Rh (D) system and Direct Coombs test in newborns.


Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones 16243 G2 and 16247 E6)Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)Anti-AB: monoclonal anti-AB (mixture of IgM antibodies of murine origin, clones 16245 F11 D8, 16247 E6 and 7821 D9)Anti-D: monoclonal anti-D (IgM antibodies of human origin, clone P3x61)Anti-D’: monoclonal anti-D (mixture of IgG and IgM antibodies of human origin, clones P3x290, P3x35, P3x61 and P3x21223 B10) (This anti-D monoclonal reagent detects weak D and partial variants of the D antigen, including the DVI variant)Ctl.: buffered solution without antibodies (control microtube)Anti-IgG: rabbit polyclonal anti-IgG in buffered low ionic strength solution (LISS) AHG: Coombs, buffered low ionic strength solution (LISS) with polyspecific anti-human globulin. Mixture of rabbit polyclonal anti-IgG and monoclonal anti-C3d antibodies, IgM antibodies of murine origin, clone 12011 D10

Storage: 2-8 ºC


DG Gel® DC Scan Ref. 210323

Technique: Evaluation of positive Direct Coombs samples. It allows differentiating red blood cells sensitized “in vivo” by IgG type immunoglobulins or the complement C3d fraction.


Clones:AHG: Coombs, buffered low ionic strength solution (LISS) with polyspecific anti-human globulin. Mixture of rabbit polyclonal anti-IgG and monoclonal anti-C3d antibodies, IgM antibodies of murine origin, clone 12011 D10Anti-IgG: (rabbit polyclonal) anti-IgG in low ionic strength solutionAnti-C3d: monoclonal anti-C3d (IgM antibodies of murine origin, clone 12011 D10)Ctl.: buffered solution without antibodies (control microtube)

Storage: 2-8 ºC


A B AB D D’ Ctl. IgG AHG

AHG IgG C3d Ctl AHG IgG C3d AHG


DG Gel® CT Ref. 210318

Technique: Confirmation of the antigens of the ABO and Rh (D) systems, ABO/ Rh compatibility test, screening of unexpected antibodies, crossmatch and autocontrol.


Clones:Anti-A: monoclonal anti-A (mixture of IgM antibodies of murine origin, clones 16243 G2 and 16247 E6)Anti-B: monoclonal anti-B (IgM antibodies of murine origin, clone 9621 A8)Anti-D: monoclonal anti-D (mixture of IgG and IgM antibodies of human origin, clones P3x290, P3x35, P3x61, P3x21223 B10) (This anti-D monoclonal reagent detects weak D and partial variants of the D antigen, including the DVI variant)Ctl.: buffered solution without antibodies (control microtube)N: buffered solution without antibodies (neutral microtubes)AHG: Coombs, buffered low ionic strength solution (LISS) with polyspecific anti-human globulin. Mixture of rabbit polyclonal anti-IgG and monoclonal anti-C3d antibodies, IgM antibodies of murine origin, clone 12011 D10

Storage: 2-8 ºC


A B D Ctrl N N AHG AHG

Grifols DG Gel®


DG Red Line

Grifols RBC reagents for the screening and identification of unexpected antibodies, reverse group and controls.

Red blood cells GrifolsReverse group determination Reference Product Presentation213659 Serigrup Diana A1/B 2 x 10 ml (A1/B)213658 Serigrup Diana A2 1 x 10 ml (A2)210215 Serigrup Diana 4 4 x 10 ml (A1/A2/B/O)

Screening of unexpected antibodies Reference Product Presentation210204 Serascan Diana 2 2 x 10 ml (I, II)210205 Serascan Diana 2P 2 x 10 ml (IP, IIP)210206 Serascan Diana 3 3 x 10 ml (I, II, III)210207 Serascan Diana 3P 3 x 10 ml (IP, IIP, IIIP)210208 Serascan Diana 4 4 x 10 ml (I, II, III, IV)210209 Serascan Diana 4P 4 x 10 ml (IP, IIP, IIIP, IVP)

Identification of unexpected antibodies Reference Product Presentation210210 Identisera Diana 11 x 5 ml (1 a 11)210211 Identisera Diana P 11 x 5 ml (1P a 11P)210212 Identisera Diana Extend 4 x 5 ml (12 a 15)210213 Identisera Diana Extend P 4 x 5 ml (12P a 15P)

Immunohematology controls Reference Product Presentation213433 DG Gel® Control 4 x 6 ml

16 IMMUNOHEMATOLOGY GENERAL CATALOGUE REAGENTS

Serigrup Diana

RBC for the determination of the reverse group

Serigrup Diana A1/B 0,8% 2 x 10 ml (A1/B)Serigrup Diana A2 0,8% 1 x 10 ml (A2)Serigrup Diana 4 0,8% 4 x 10 ml (A1/A2/B/O)

Technical specifications

• RBC suspensions from A1, A

2, B and 0 donors for the determination of the reverse group.

• Each vial of Serigrup Diana contains 10 ml of the corresponding human red blood cells in a 0.8% suspension in a buffered solution with preservatives. Each vial comes from a single donor (no pools).

• Ready to use; stored at 2-8 ºC.

• Reagents standardized with DG Gel® cards for Grifols Clear Card Technology column agglutination technique, and totally adapted to Grifols instrumentation.

DG Red Line


Serigrup Diana A2

Serigrup Diana A1/B

Serigrup Diana 4

DG Red Line


Serascan Diana

Red blood cells for the screening of unexpected antibodies

Serascan Diana 2 2 x 10 ml (I, II)Serascan Diana 2P 2 x 10 ml (IP, IIP)Serascan Diana 3 3 x 10 ml (I, II, III)Serascan Diana 3P 3 x 10 ml (IP, IIP, IIIP)Serascan Diana 4 4 x 10 ml (I, II, III, IV)Serascan Diana 4P 4 x 10 ml (IP, IIP, IIIP, IVP)


• Panel of 2, 3 or 4 cells with an antigen configuration specifically selected for the screening of the most clinically relevant antibodies.

• Each vial of Serascan Diana (2, 3 and 4 cells) contains 10 ml of human red blood cells from the O blood group, in 0.8% suspensions in a buffered solution with preservatives. Each vial comes from a single O group donor (no pools).

• Ready to use; stored at 2-8 ºC.• Complementary range of papainized red blood cells available (P).• Reagents standardized with DG Gel® cards for Grifols Clear Card Technology column agglutination technique, and totally adapted to

Grifols Instrumentation.

Optimization and safety in Type & ScreenSerascan 4 Cells

• Panel of 4 cells selected for the maximum expression of antigens associated with the most clinically relevant antibodies.• Expression of all the antigens required by international standards: D, C, E, c, e, K, k, Kpb, Jsb, M, N, S, s, Fya, Fyb, Jka, Jkb, Lea,

Leb, Lub, P1,Xga.• Routine presence of antigen Cw. • Expression of all antigens associated with antibodies that most commonly demonstrate dosage: Rh, Duffy, MNS y Kidd.• Homozygous expression for the following antigens: D, C, c, E, e, Fya, Fyb, Jka, Jkb.• R

1R

1 and R

2R

2 profiles are present (according to the requirements of the majority of international standards).

DG Gel® + Serascan Diana 4Optimization and safety in Type & Screen

4-cell panel for the screening of unexpected antibodiesMaximum efficiency and information per card and testIncreased safety compared to 2 and 3 cellsOptimization of the unique 8-column format

DG Red Line


Serascan Diana 2

Serascan Diana 2P

Serascan Diana 3

Serascan Diana 3 P

Serascan Diana 4

Serascan Diana 4 P

DG Red Line


Identisera Diana

Red blood cells for the identification of unexpected antibodies

Identisera Diana 11 x 5 ml (1 a 11)Identisera Diana P 12 x 5 ml (1P a 11P)Identisera Diana Extend 4 x 5 ml (12 a 15)Identisera Diana Extend P 5 x 5 ml (12P a 15P)


• Panel of 11 cells + panel of 4 cells with an antigen configuration specifically selected for the individual identification of the most clinically relevant antibodies.

• Each vial of Identisera contains 5 ml of human red blood cells from the O blood group, in 0.8% suspensions in a buffered solution with preservatives. Each vial comes from a single O group donor (no pools).

• Ready to use; storage: 2-8 ºC.• Complementary range of papainized red blood cells available (P).• Reagents standardized with DG Gel® cards for Grifols Clear Card Technology column agglutination technique, and totally

adapted to Grifols instrumentation.

Complete identification with 15 cells + controlIdentisera Diana + Identisera Diana Extend

• Primary panel of 11 cells + complementary panel of 4 cells.• Expression of the following antigens: D, C, Cw, c, E, e, K, k, Kpb, Jsb, M, N, S, s, Fya, Fyb, Jka, Jkb, Lea, Leb, Lua, Lub, P1, Xga.• Expression of all antigens associated with antibodies that most commonly demonstrate dosage: Rh, Duffy, MNS y Kidd.• Three Kell-positive cells.• Homozygous antigens: M, N, S, s, C, c, E, e, D, Lub, k, Kpb, Jsb, Fya, Fyb, Jka, Jkb.• Two homozygous cells minimum for: Fya, Fyb, Jka, Jkb, S, s, M, N.• Presence of the following phenotypes: P

1 negative, Le (a-b-), 2 cells Le (a+).

• Unique panel with 3 R1R

1 cells and 4 rr homozygous cells and complementary Jk, Fy and MNS cells.

• When anti-D, anti-C or anti-E are present, it allows for the detection of a second antibody for Kidd, Duffy, MNS or Kell.• There are 4 possible complementary combinations of Fy and Jk.

Complete identification with 15 cells + control

Greater number of homozygous and complementary red blood cells for better detection and identification of unexpected antibodies.Maximum efficiency and information per card and test.Optimization of the unique 8-column format.

DG Red Line


Identisera Diana

Identisera Diana Extend

Identisera Diana P

Identisera Diana Extend P

DG Red Line


DG Gel® Control

Reagent for routine internal control in Immunohematology Laboratories


• DG Gel® Control is a manual or automated control of typing systems for ABO and Rh(D) in DG Gel® cards. It can also be used as a control for screening unexpected antibodies.

• Each kit contains four 6 ml tubes:- Tube A: Group A Rh(D) negative with anti-B and anti-D- Tube B: Group O Rh(D) positive with anti-A and anti-B- Tube C: Group B Rh(D) positive with anti-A and anti-Kell- Tube D: Group AB Rh(D) positive

• Ready to use; storage: 2-8ºC.

• DG Gel® Control suspensions are used as control samples with DG Gel® reagents.

• Reagents standardized with DG Gel® cards for Grifols Clear Card Technology column agglutination technique, and totally adapted to Grifols instrumentation.

DG Red Line


Liquid antiserum for typing erythrocytes used with DG Gel® Neutral or DG Gel® Coombs cards in the gel technique or in the manual tube technique.

DG Hemotype

Reference Description Presentation

213164 Anti-A (monoclonal) Clone Birma-1 10 ml

213165 Anti-B (monoclonal) Clone LB-2 10 ml

213166 Anti-AB (monoclonal) Clone ES-4/ES-15 10 ml

213097 Anti-A1 (Dolichos biflorus Lectin) 5 ml

213068 Anti-AHP (Helix pomatia Lectin) 5 ml

213069 Anti-H (Monoclonal) Clone 10934C11 5 ml

213107 Anti-D (Monoclonal, human IgM) Clone RUM-1 10 ml

213108 Anti-D (Monoclonal, human IgG/IgM) Clone MS-26/TH-28 10 ml

213109 AT Anti-CDE (polyclonal, human IgG) 10 ml

213070 Anti-Cw (monoclonal) Clone MS-110 5 ml

213140 Anti-Cw (monoclonal) Clone MS-110 for card technique 5 ml

213167 Anti-C (monoclonal, human IgM) Clone MS-24/P3x25513G8 5 ml

213168 Anti-C (monoclonal, human IgM) Clone MS-273 5 ml

213169 Anti-c (monoclonal, human IgM) Clone MS-33 5 ml

213170 Anti-c (monoclonal, human IgM) Clone MS-35 5 ml

213171 Anti-E (monoclonal, human IgM) Clone MS-258/906 5 ml

213172 Anti-E (monoclonal, human IgM) Clone MS-12/-260 5 ml

213173 Anti-e (monoclonal, huma IgM) Clone MS-16/-21/-63 5 ml

213174 Anti-e (monoclonal, huma IgM) Clone MS-62/MS-69 5 ml

213175 Anti-P1 (goat) 5 ml

213071 Anti-P1 (monoclonal) Clone 650 5 ml

213072 Anti-M (monoclonal, mouse) Clone 11H2/M1-2F11 5 ml

213073 Anti-N (monoclonal, mouse) Clone 20H12/MN879 5 ml

213074 Anti-S (monoclonal) Clone MS-94 5 ml

213075 Anti-S (polyclonal, human IgG) Coombs 5 ml

213099 Anti-s (polyclonal, human IgG) Coombs 5 ml


213176 Anti-K (K1) (monoclonal human IgM) Clone MS-56 5 ml

213177 Anti-K (K1) (monoclonal, human IgM) Clone AEK-4 5 ml

213178 Anti-K (K1) (polyclonal, human IgG) Coombs 5 ml

213076 Anti-Cellano (polyclonal human IgG) Coombs 5 ml

213147 Anti-Cellano (polyclonal human IgG) Coombs for card technique 5 ml

213110 Anti-Fya (polyclonal human IgG) Coombs 5 ml

213112 Anti-Fyb (polyclonal human IgG) Coombs 5 ml

213114 Anti-Jka (polyclonal human IgG) Coombs 5 ml

213106 Anti-JKb (polyclonal human IgG) Coombs 5 ml

213179 Anti-Jka (monoclonal human IgM) Clone MS-15 5 ml

213180 Anti-Jkb (monoclonal human IgM) Clone MS-8 5 ml

213116 Anti Lea (monoclonal mouse) Clone LM112/161 5 ml

213129 Anti-Leb (monoconal mouse) Clone LM129/181 5 ml

213079 Anti-Lua (polyclonal human IgG) Coombs 2 ml

213080 Anti-Lub (polyclonal human IgG) Coombs 2 ml

213093 Anti-Kpa (polyclonal human IgG) Coombs 2 ml

213100 Anti-Kpb (polyclonal human IgG) Coombs 2 ml

213081 Anti-Xga (polyclonal human IgG) Coombs 2 ml

213082 Anti Coa (polyclonal human IgG) Coombs 2 ml

213094 Anti-Cob (polyclonal human IgG) Coombs 2 ml

213083 Anti-Dia (polyclonal human IgG) Coombs 2 ml

213084 Anti-Wra (polyclonal human IgM) 2 ml

DG Hemotype

Reference Description Presentation

213085 AHG (Coombs serum, polyclonal, blend) 10 ml

213086 AHG (Coombs serum, polyclonal, sheep) monospecific IgG 5 ml

213087 AHG (Coombs serum, polyclonal, sheep) monospecific IgA 2 ml

213088 AHG (Coombs serum, polyclonal, sheep) monospecific IgM 2 ml

213089 AHG (Coombs serum, polyclonal, sheep) monospecific C3b (beta 1C/A) 2 ml

213090 AHG (Coombs serum, monoclonal) monospecific C4 (beta 1 E) 2 ml

213091 AHG (Coombs serum, monoclonal) monospecific C3d (alpha 2 D) 2 ml

213092 Bromelin 10 ml

213101 Control Solution (for testing of monoclonal reagents) 10 ml

213095 Liss 10 ml 10 ml

213096 Liss 50 ml 50 ml

213124 Albumin 22% 10 ml

213123 Albumin 30% 10 ml

Others:

Reagents manufactured by Antitoxin GmbH, Germany.

Auxiliary reagents and solutions

DG Gel SolLow ionic strength solution (LISS) for the preparation of RBC suspensions.

DG CellMediaLiquid preservative for the preparation of 0.8% RBC suspension to be used in DG Gel® cards.

DG PapainEnzymatic auxiliary solutions for gel card techniques.

Diana Fluid AConcentrated reagent used for the internal washing of “in vitro” diagnostic devices.

Diana Fluid BConcentrated reagent used for the internal washing of “in vitro” diagnostic devices.

Reference Product Presentation

210354 DG Gel Sol 2 x 100 ml

210385 DG CellMedia 1 x 500 ml

210357 DG Papain 1 x 10 ml

213679 Diana Fluid A 12 x 125 ml

213678 Diana Fluid B 12 x 125 ml

DG Gel Sol DG Papain

Diana Fluid A Diana Fluid B


INSTRUMENTATIONFully automated

Semiautomated

Manual

Accessories

INSTRUMENTATION

INSTRUMENTATION IMMUNOHEMATOLOGY GENERAL CATALOGUE 27

Instrumentation

Reference Product Description

213787 WADiana® Compact Fully automated instrument for the processing of DG Gel® cards


213717 Diana Processor Semiautomated instrument for the processing of DG Gel® cards

213731 Diana Reader Reader for microplates and DG Gel® cards


213734 DG Therm Digital incubator for the processing of DG Gel® cards

210363 DG Spin Digital centrifuge for the processing of DG Gel® cards


210370 DG Rack DG Gel® cards work station (3 modules for cards + 1 module for reagents)

210371 DG Rack reagent module Separate extra module for reagents (4 x 4 vials)

210372 DG Rack cards module Separate extra module for cards and tubes (6 cards + 12 tubes)

213600 DG Stepper Piepette of fix volumes (10, 25, 50 µl)

213601 DG Dispenser Dispenser of fix volumes (500 µl, 1 ml)

Fully automated

Semiautomated

Manual

Accessories

28 88

Fully automated instrument for the processing of DG Gel® cards for blood typing. Its “walk away” system is designed for automatic, continuous and integrated processing of all the steps in the different techniques of blood typing and investigation of unexpected antibodies.

- Positive identification of samples and reagents with batch and expiration control and compatibility verification.

- Monitoring of levels of reagents, diluents and wash and disposal solutions.

- Dilution station with auto-wash, non-disposable.

- Automatic verification by imaging of dispensing in all the wells.

- Incubation of cards.

- Centrifugation of cards.

- Digitized results reading.

- Results interpretation.

- Report generation.

IMMUNOHEMATOLOGY GENERAL CATALOGUE INSTRUMENTATION

Fully automated

88INSTRUMENTATION IMMUNOHEMATOLOGY GENERAL CATALOGUE 29

Automática

WADiana Shuttle:Bidirectional connection for several WADiana® units. This interconnectivity allows 2 or more WADiana® to work as a single analytical instrument and provides:- Efficient throughput.- Functional random access.- Better loading accessibility.

Emergency sample management:- New pre-programmed techniques for emergency sample processing.

- More flexible in managing emergency samples with easy application Diana Reader to the system.

Improved computer applications:- New user-friendly graphic interface.

- Enhanced central computer – hospital communication.

- New tracking and statistics module for laboratory data management.

- Intuitive Quality Control program application (WADiana® QC software) for even easier handling of routine internal/external controls.

- Easy to customize configurable reports.

Hardware improvements:- New pre-set techniques offering increased flexibility in incubation for

the optimization of techniques at 37 ºC.

- New fluidics management and control. Less preventive maintenance.

30 88IMMUNOHEMATOLOGY GENERAL CATALOGUE INSTRUMENTATION

Semiautomated

Semiautomated instrumentation for the processing of DG Gel® cards and microplates for blood typing tests.

This instrument carries out sample and reagents identification, dilutions, dispensing and incubation.

The main features:- Easy to program and perform the techniques.- Safety in sample handling and processing.- Identification through portable.- Flexible: can use any primary tube size.- Automatic preparation of all RBC suspensions.- Perforation of card seal prevents contamination.- Card incubation at the appropriate temperature: 37°C or 25°C.

Diana Processor

Diana Reader- Twin reader for DG Gel® cards and microplates.- Accessory for reading the results and recording data in the system software.- More flexible in emergency sample management when connected to the WADiana®.- Positive identification of samples and regents by bar code.

Technical specifications:- Reading time: 2s (cards), 7s (microplates)- Voltage: 100-240 V- Frequency: 50-60 Hz- Power: 40 W

88

Digital incubator for the manual processing of Grifols DG Gel® cards.

Main characteristics:- 2 independent incubation zones with a capacity for 12 DG Gel® cards and 12 test tubes in each zone.- Digital user interface screen for control and visualization of remaining incubation time and real temperature for each zone.- Fixed pre-set temperature of 37 ºC.- Pre-set incubation time of 15 minutes, which can be adjusted by the user.- Audible programmable alarm to notify end of incubation period.- Visual and audible indication of any error or power failure.- Quick procedure guide included.- Removable trash bin.

Quality tracking and records:- Record relevant information and possible incidents produced during operating (log file) with computerized connection.- External communication port for periodic instrument verifications.

Technical specifications:- Capacity: 24 DG Gel® cards and 24 testing tubes- Temperature: 37 ºC ± 1 ºC- Time: 15 min. (variable)- Voltage: 100-240 V- Frequency: 50-60 Hz- Consumption: 270 W

DG THERM

INSTRUMENTATION IMMUNOHEMATOLOGY GENERAL CATALOGUE 31

Manual

32 88IMMUNOHEMATOLOGY GENERAL CATALOGUE INSTRUMENTATION

Manual

Digital centrifuge for the manual processing of Grifols DG Gel® cards.

Main characteristics:- Simultaneous centrifuge of up to 24 DG Gel® cards.- Removable and exchangeable spinning head.- Pre-defined centrifugal parameters for optimum DG Gel® card processing: acceleration, speed, braking and time.- Digital user interface visor for control and visualization of centrifuge speed and time remaining for processing.- Programmable audible alarms for end of centrifugal time periods.- Visual and audible indication of any error or power failure.- Imbalance system detects incorrect placement of DG Gel® cards on the spinning head.- Quick procedure guide included.

Quality tracking and records:- Record relevant information and possible incidents produced during operating (log file) with computerized connection.- External communication port for periodic instrument verifications.

Technical specifications:- Capacity: 24 DG Gel® cards- Speed: 990 rpm- Time: 9 min.- Voltage: 100-240 V- Frequency: 50-60 Hz- Consumption: 50 W

DG Spin

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DG Rack

DG Stepper- DG Stepper is a hand held dispenser based on air displacement for accurate liquid dispensing.- This instrument has been specially designed for the gel card system.- With a single loading the operator can deliver 10 µl into 32 wells, 25 µl into 12 wells or 50 µl into 6 wells.- Fast and safe tip removal after use.- DG Stepper is designed for both right and left handed users.

DG Dispenser- The DG Dispenser is used for suspension solutions, dispensing them in

500 or 1000 µl for the preparation of red blood cell suspensions.- The dispenser fits on 100 and 500 ml bottles.

Auxiliary accessories

Technical features:- Work station for the manual processing of DG Gel® cards and sample

tubes.

- Very flexible and easy to personalize.

- Totally adaptable to right and left handed people.

- Large capacity - Up to 24 cards. - Up to 24 sample tubes (Ø 16 mm).- Up to 48 dilution tubes (Ø 13 mm).- Up to 16 reagent vials (5 & 10 ml).- 2 bottles DG Gel Sol diluent.

- Configurable racks- 4 small racks for 4 reagent vials each.- 3 racks for 6 DG Gel® cards and 12 sample tubes each.- Racks are modular, interchangeable & storable (4ºC).- Reagent racks include positions for caps/droppers.- Individual racks are available as accessories.

- Support tray to configure an individual work rack.

HEMOVIGILANCE HEMOVIGILANCE

Gricode®

Blue

Hemovigilance is defined as a set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of its recipients), intended to collect and assess information on unexpected or un-desirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence and recurrence.Hemovigilance should cover the entire transfusion chain, as incidents can occur in any of the steps: from donor selection to the transfusion itself.

Today Grifols offers a complete range of systems, products and services to hospitals and transfusion centers so that they can apply a through Hemovigilance system with the highest levels of safety and efficacy and thereby offer the best quality care possible.

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Hemovigilance

36 IMMUNOHEMATOLOGY GENERAL CATALOGUE HEMOVIGILANCE

Gricode®

Gricode® is a computerized, autonomous and portable recording system for the guarantee of transfusion safety.

Based on positive, objective and correct identification of the elements involved in transfusion, it identifies the receptor, samples, documents and blood components through bar codes and their movements are recorded in situ through a terminal which records this information through a bar code reader.

Bracelet- Flexible safety id bracelet.- Adjustable and comfortable for all kinds of patients.- Unbreakable plastic fastener.- The bracelet incorporates a bar code labeling system.

LabelsNumbered pre-printed labels with bar code for the objective identification of: patient bracelet, sample, request, transfusion document and blood component to be transfused.

The labeling system assigns an individual and unrepeated transfusion safety number.

Portable terminal- Autonomous portable device for reading, capturing, recording and interpreting of data.- PC independent.- Includes different programs to adapt to the needs of the blood bank.- Accompanies each task with an electronic signature.- Interprets and compares the bar codes of each different identified elements.- The reader can download bar code data to the Gricode® Software which can later be used by BLUE.

Data Management SoftwareGricode® software allows the user to see the results from different readings and controls as carried out as part of the Hemovigilance system. It offers a compete and exhaustive record of all the steps carried out from the collection of the sample, its receipt by the blood bank, the compatibility tests, its delivery, and lastly, transfusion and possible post transfusion reactions.

- Guarantees an unbreakable id association between patient, sample, request and blood component.- Ensures that data is correctly recorded into the lab system preventing manual transcription errors.- Carries out a computerized check of the blood component to be transfused: 1st Electronic Crossmatch test.- Carries out a computerized check of the patient to receive the transfusion: 2nd Electronic Crossmatch test.- Sends the first post-transfusion report: Hemovigilance at bedside.- Monitors and follows up all the transfusion process through local network systems in real time.

BLUE (Blood Unit Expert)

BLUE is a modular computer application for the integral management of the Blood Bank. It ensures quality and traceability of the donation, fractionation, validation, distribution and transfusion of blood components.

It records, checks and uses any and all data used in daily tasks from stocks ma-nagement to guaranteeing compatibility to managing communication reports for Hemovigilance.

Easy- User friendly touch screen.- Optimization of bar code use: for objective readings and preventing manual transcription of data.- Report printing: individual, automatically filled, configurable to each center.- Label printing: for documents, samples and blood component units.- User assistance in real time.

Compatible & Secure- Alarms for incidents and expirations.- Access code and user identification program with electronic signature validation.- Electronic request for blood components.- Integration of Gricode® portable terminals, avoiding manual transcription. - Connectable to all types of autoanalyzers such as WADiana® or other computer applications.- Bidirectional connection with the hospital management program.- Can be linked to hospital billing programs.- ISBT 128 compatibility.- HL7 connectivity.

Modular- Mother-child program: Anti-D analysis, management, appointment, prophylaxis and therapy for pregnant women, mothers

and neonates.- Donor program: donation process control and management of blood components.- Patient program: integrated management of the whole transfusion chain.- Hemovigilance program: control, communication and handling of incidents and adverse events related to transfusion.

Integrated official post-transfusion reports. Automatic creation, processing and issue of documentation.- Auto-transfusion program: easy, simple and specific management of autologous donation process.- Instrument and reagent program: census, registration and planning of inspections, maintenance, calibrations, quality

controls and reagent lots.- Web program: generation and distribution of online requests, viewings patient records, inter-center communications, inventory

management.

Hemovigilance and Traceability- Adapted to current working and communication protocols according to Hemovigilance Committees.- Integration of official reporting forms.- Electronic crossmatch test: connectable to autoanalyzers and the Gricode® system, transfusion safety and hemovigilance

at bedside.- Records all the operations from pre-donation to the end of the transfusion and follow up on post-transfusion reactions.- Sera archive.

HEMOVIGILANCE IMMUNOHEMATOLOGY GENERAL CATALOGUE 37

Diagnostic Grifols, S.A.

Pg. Fluvial, 24. 08150 Parets del Vallès, Barcelona - ESPAÑATel. [34] 935 710 400 Fax [34] 935 731 132 www.grifols.com

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