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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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Negative Serum Control - 10888234500520

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404574
Not in Commercial Distribution

  • 10888234500520 ()
404574

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

Specimen Diluent - 10888234500445

For Use with LIFECODES B-Screen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403831
Not in Commercial Distribution

  • 10888234500445 ()
403831

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

Substrate Buffer - 10888234500377

For Use with Factor VIII Antibody Screen, PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LIFECODES QuikScreen, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403613
Not in Commercial Distribution

  • 10888234500377 ()
403613

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

Stopping Solution - 10888234500360

For Use with PF4 Enhanced (X-HAT13 & X-HAT45), PF4 IgG (HAT13G & HAT45G), LIFECODES B-Screen, LIFECODES QuikScreen, DonorScreen-HLA Class I and Class II, Pak12, Pak12G, Pak2-LE, PakAuto, and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403603
Not in Commercial Distribution

  • 10888234500360 ()
403603

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

ThromboType®1 - 10888234500261

ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE1
In Commercial Distribution

  • 10888234500261 ()
THROMBOTYPE1

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

PakAuto® - 10888234500247

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
Not in Commercial Distribution

  • 10888234500247 ()
PAKAUTO

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

LIFECODES® QuikScreen® - 10888234500094

LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
QS12G
Not in Commercial Distribution

  • 10888234500094 ()
QS12G

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

LIFECODES® B-Screen® - 10888234500063

LIFECODES B-Screen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class II antigens.
IMMUCOR GTI DIAGNOSTICS, INC.
BCSG
Not in Commercial Distribution

  • 10888234500063 ()
BCSG

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

Dilution Solution - 10888234400769

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

  • 10888234400769 ()
628515

  • Buffered sample diluent IVD

Dilution Solution - 10888234400745

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628155
Not in Commercial Distribution

  • 10888234400745 ()
628155

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