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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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Specimen Diluent - 10888234500704

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404582
Not in Commercial Distribution

  • 10888234500704 ()
404582

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

Stopping Solution - 10888234500698

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404585
Not in Commercial Distribution

  • 10888234500698 ()
404585

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

Concentrated Wash (10X) - 10888234500681

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404562
Not in Commercial Distribution

  • 10888234500681 ()
404562

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

Cell Resuspension and Preservative Solution - 10888234500599

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404590
Not in Commercial Distribution

  • 10888234500599 ()
404590

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

Anti-Human IgG/A/M Conjugate - 10888234500575

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404588
Not in Commercial Distribution

  • 10888234500575 ()
404588

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

Normal Platelet Control (Negative Eluate Control) - 10888234500551

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404578
Not in Commercial Distribution

  • 10888234500551 ()
404578

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

Negative Serum Control - 10888234500544

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404577
Not in Commercial Distribution

  • 10888234500544 ()
404577

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

Negative Serum Control - 10888234500537

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404576
Not in Commercial Distribution

  • 10888234500537 ()
404576

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

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

Negative Serum Control - 10888234500513

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404573
Not in Commercial Distribution

  • 10888234500513 ()
404573

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