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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 - 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

Aurora Xi Software - 04086000101516

Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system

Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed - 04086000100991

For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2367
In Commercial Distribution

  • 14086000100998 ()
  • 04086000100991 ()
4R2367

  • Apheresis system tubing set

Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed - 04086000100984

For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2365
In Commercial Distribution

  • 04086000100984 ()
  • 14086000100981 ()
4R2365

  • Apheresis system tubing set

Aurora Plasmapheresis System - 04086000100236

Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.
Fresenius Kabi AG
6R4601
In Commercial Distribution

  • 04086000100236 ()
6R4601

  • Apheresis system

ALYX 2RBC LR KIT - 04086000100199

For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5720
In Commercial Distribution

  • 04086000100199 ()
  • 14086000100196 ()
X4R5720

  • Apheresis system tubing set

Acrodose PLus System - 10887691310697

Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
HAEMONETICS CORPORATION
732-83
In Commercial Distribution

  • 30887691310691 ()
  • 10887691310697 ()


  • Blood/tissue storage/culture container

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
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