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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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LIFECODES LifeScreen XP - 10888234500841

LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
628220
In Commercial Distribution

  • 10888234500841 ()
628220

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

Dilution Solution - 10888234500827

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515UDI
In Commercial Distribution

  • 10888234500827 ()
628515UDI

  • Buffered sample diluent IVD

LIFECODES MATCH IT! Antibody Software - 10888234500810

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888627
In Commercial Distribution

  • 10888234500810 ()
888627

  • Laboratory instrument/analyser application software IVD

LIFECODES MATCH IT!™ DNA Software v1.3 - 10888234500803

No Description
IMMUCOR GTI DIAGNOSTICS, INC.
888623
In Commercial Distribution

  • 10888234500803 ()
888623

  • Laboratory instrument/analyser application software IVD

PakAuto® - 10888234500728

PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKAUTO-MAYO
Not in Commercial Distribution

  • 10888234500728 ()
PAKAUTO-MAYO

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

PakPlus® - 10888234500674

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/II.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS100
Not in Commercial Distribution

  • 10888234500674 ()
PAKPLUS100

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

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
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