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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Capture-R Ready Indicator Red Cells - 10888234002307

Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells.
IMMUCOR, INC.
0066907
In Commercial Distribution

  • 10888234002307 ()
0066907

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Capture LISS - 10888234002291

Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma.
IMMUCOR, INC.
0066908
In Commercial Distribution

  • 10888234002291 ()
0066908

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Monoclonal Control - 10888234002178

Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has one (1) vial.
IMMUCOR, INC.
0066087
In Commercial Distribution

  • 10888234002178 ()
0066087

  • Multiple immunohaematology test IVD, control

Capture LISS - 10888234002147

Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the single 57 mL bottle version.
IMMUCOR, INC.
0006418
In Commercial Distribution

  • 10888234002147 ()
0006418

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

CMT Plates - 10888234001591

CMT Plates are intended to be used in hemagglutination assays on Immucor automated instruments. CMT Plates are composed of micro-wells coated to block the nonspecific adsorption of red blood cells or serum proteins to the plastic wells. CMT Plates are supplied in a plate format. Each plate has twelve strips on a support frame and each strip has eight micro-wells. Strips can be used individually or in multiples. This product configuration is forty (40) microplates.
IMMUCOR, INC.
0089000
In Commercial Distribution

  • 10888234001591 ()
0089000

  • Immunohaematology/blood bank analyser IVD

Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum - 10888234001577

Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
IMMUCOR, INC.
0066905
In Commercial Distribution

  • 10888234001577 ()
0066905

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

Capture-P - 10888234001560

Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is designed to detect the unexpected antiplatelet antibodies (antibody screening test) in a patient or donor population.
IMMUCOR, INC.
0066904
In Commercial Distribution

  • 10888234001560 ()
0066904

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

Capture-R Select - 10888234001553

The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping).
IMMUCOR, INC.
0066903
In Commercial Distribution

  • 10888234001553 ()
0066903

  • Solid-phase red blood cell adherence antibody/antigen IVD

corQC EXTEND Complete - 10888234001331

corQC EXTEND Complete is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a five vial set.
IMMUCOR, INC.
0066297
In Commercial Distribution

  • 10888234001331 ()
0066297

  • Multiple immunohaematology test IVD, control

Capture-P Control set - 10888234001294

The Capture-P Control set is composed of both negative and weak positive control material to control both the Capture-P and Capture-P Ready-Screen tests.
IMMUCOR, INC.
0066248
In Commercial Distribution

  • 10888234001294 ()
0066248

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

DAT Positive Control Cell - 10888234001119

DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the four (4) vial configuration.
IMMUCOR, INC.
0066125
In Commercial Distribution

  • 10888234001119 ()
0066125

  • Multiple immunohaematology test IVD, control

GammaZyme-F - 10888234000709

GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD

Capture-R Select - 10888234000655

Capture-R Select solid phase system provides modified micro-wells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping). This product is the five (5) plate configuration.
IMMUCOR, INC.
0006446
In Commercial Distribution

  • 10888234000655 ()
0006446

  • Microplate IVD

Capture-R Ready Indicator Red Cells - 10888234000600

This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration.
IMMUCOR, INC.
0006428
In Commercial Distribution

  • 10888234000600 ()
0006428

  • Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody

Capture LISS - 10888234000570

Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with one vial packaged.
IMMUCOR, INC.
0006419
In Commercial Distribution

  • 10888234000570 ()
0006419

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Platelet Wash and Storage Solution - 10888234000488

Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.
IMMUCOR, INC.
0005035
In Commercial Distribution

  • 10888234000488 ()
0005035

  • Platelet storage solution

corQC EXTEND 1, 2, and 3 - 10888234000341

corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set.
IMMUCOR, INC.
0002417
In Commercial Distribution

  • 10888234000341 ()
0002417

  • Multiple immunohaematology test IVD, control

Bovine Albumin Solution 22% - 10888234000235

Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatch, antibody identification and antibody titration procedures. This product is prepared from bovine serum albumin and is the ten (10) vial configuration.
IMMUCOR, INC.
0002327
In Commercial Distribution

  • 10888234000235 ()
0002327

  • Bovine serum albumin (BSA) immunohaematology reagent IVD

Checkcell (Weak) - 10888234000204

Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002226
In Commercial Distribution

  • 10888234000204 ()
0002226

  • Multiple immunohaematology test IVD, control

Checkcell - 10888234000181

Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
IMMUCOR, INC.
0002224
In Commercial Distribution

  • 10888234000181 ()
0002224

  • Multiple immunohaematology test IVD, control

3 x 4% E-Gel 48 Gels - 10888234500667

For Use with ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution

  • 10888234500667 ()
EGEL48

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

PNPP Substrate - 10888234500650

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
403594
Not in Commercial Distribution

  • 10888234500650 ()
403594

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500643

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404601
Not in Commercial Distribution

  • 10888234500643 ()
404601

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500636

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404600
Not in Commercial Distribution

  • 10888234500636 ()
404600

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500629

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404598
Not in Commercial Distribution

  • 10888234500629 ()
404598

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG/A/M Conjugate - 10888234500582

For Use with Pak12 and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404589
Not in Commercial Distribution

  • 10888234500582 ()
404589

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Platelet Control (Positive Eluate Control) - 10888234500568

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404579
Not in Commercial Distribution

  • 10888234500568 ()
404579

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Eluting Solution - 10888234500490

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404565
Not in Commercial Distribution

  • 10888234500490 ()
404565

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Buffering Solution - 10888234500476

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404560
Not in Commercial Distribution

  • 10888234500476 ()
404560

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Concentrated Wash (10X) - 10888234500407

For Use with Factor VIII Antibody Screen and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403622
In Commercial Distribution

  • 10888234500407 ()
403622

  • HLA class I antibody screening IVD, reagent

ThromboType® - 10888234500285

ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution

  • 10888234500285 ()
THROMBOTYPE

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

PakPlus® - 10888234500254

The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/IIa.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS
In Commercial Distribution

  • 10888234500254 ()
PAKPLUS

  • HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)

Pak2-LE - 10888234500230

Pak2-LE is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK2-LE
Not in Commercial Distribution

  • 10888234500230 ()
PAK2-LE

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)

Positive Control Serum - 10888234400615

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403892
Not in Commercial Distribution

  • 10888234400615 ()
403892

  • HLA class II antigen tissue typing IVD, kit, multiplex

Negative Control Serum - 10888234400592

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

  • HLA class I antigen tissue typing IVD, kit, multiplex

LIFECODES Wash Buffer - 10888234400578

For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628221
Not in Commercial Distribution

  • 10888234400578 ()
628221

  • HLA class I antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400523

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628213
Not in Commercial Distribution

  • 10888234400523 ()
628213

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Conjugate Concentrate - 10888234400509

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628212
In Commercial Distribution

  • 10888234400509 ()
628212

  • HLA class I & II antigen tissue typing IVD, reagent

LIFECODES MATCH IT!™ DNA Software v1.2 - 10888234400394

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
Not in Commercial Distribution

  • 10888234400394 ()
888623

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES LSA Class I - 10888234400332

LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
265100IVD
In Commercial Distribution

  • 10888234400332 ()
265100IVD

  • HLA class I antigen tissue typing IVD, kit, multiplex

LIFECODES Class II IDv2 for use with Luminex - 10888234400301

LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

  • HLA class II antigen tissue typing IVD, kit, multiplex

LIFECODES TAQ Polymerase - 10888234400134

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
628075
In Commercial Distribution

  • 10888234400134 ()
628075

  • DNA amplification enzyme reagent IVD

LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine - 10888234400066

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628923
Not in Commercial Distribution

  • 10888234400066 ()
628923

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-C eRES SSO Typing Kit for use with Luminex - 10888234400059

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628921
In Commercial Distribution

  • 10888234400059 ()
628921

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex - 10888234400035

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628917
In Commercial Distribution

  • 10888234400035 ()
628917

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B SSO Typing Kit for use with Luminex - 10888234400028

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628915
Not in Commercial Distribution

  • 10888234400028 ()
628915

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex - 10888234400011

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628913
In Commercial Distribution

  • 10888234400011 ()
628913

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-A SSO Typing Kit - 10888234400004

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628911
Not in Commercial Distribution

  • 10888234400004 ()
628911

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Carrier Box, ETC, Slide, IVD - 10888234102670

No Description
BIOARRAY SOLUTIONS LTD
800-20301
In Commercial Distribution

  • 10888234102670 ()
800-20301

  • Optical laboratory instrument performance standard calibrator/control IVD, reusable

Precise TypeTM HEA BeadCheck Kit - 10888234102632

No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control
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