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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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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

Positive Serum Control - 10888234500612

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution

  • 10888234500612 ()
404597

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

Positive Serum Control - 10888234500605

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404596
Not in Commercial Distribution

  • 10888234500605 ()
404596

  • 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

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

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

Negative Serum Control - 10888234500506

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404572
Not in Commercial Distribution

  • 10888234500506 ()
404572

  • 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

Anti-Human IgG Conjugate - 10888234500469

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution

  • 10888234500469 ()
404558

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

Anti-Human IgG Conjugate - 10888234500452

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution

  • 10888234500452 ()
404557

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

Welly - 00372663171053

Bandages with TA ointment
WELLY HEALTH PBC
WLY1027
In Commercial Distribution

  • 00372663171053 ()


  • First aid kit, medicated

T-handle - 04250337104841

T-Handle with Torque Limiter
Joimax GmbH
JMPS1022ST
In Commercial Distribution

  • 04250337104841 ()
JMPS1022ST

  • Surgical instrument handle, non-torque-limiting
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