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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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COBE® Spectra - 05020583704008

Single-Needle Extended Life Platelet Set With LRS® Chamber
TERUMO BCT, INC.
70400
Not in Commercial Distribution

  • 05020583704008 ()
  • 35020583704009 ()


  • Blood transfer set

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

ADAM-rWBC System - 08809317540276

ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen.
NanoEnTek, Inc.
ADAM-rWBC System
In Commercial Distribution

  • 08809317540276 ()
ADAM-rWBC System

  • White blood cell count IVD, kit, cell count

ADAM-rWBC Kit - 08809317540269

It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
NanoEnTek, Inc.
AD1K-050
In Commercial Distribution

  • 08809317540269 ()
AD1K-050

  • White blood cell count 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

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

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

Pak12®G - 10888234500223

Pak12G assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12G
Not in Commercial Distribution

  • 10888234500223 ()
PAK12G

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