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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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ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.
NanoEnTek, Inc.
ADAMII
In Commercial Distribution

  • 08809317540627 ()


  • Haematological cell analyser IVD
ADAM-rWBC2 System is composted ADAM-rWBC2(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 the human specimen.
NanoEnTek, Inc.
ADAM-rWBC2 System
In Commercial Distribution

  • 08809317540504 ()
ADAM-rWBC2 System

  • White blood cell count IVD, kit, cell count
ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
NanoEnTek, Inc.
ADAM-rWBC2
In Commercial Distribution

  • 08809317540498 ()
ADAM-rWBC2

  • White blood cell count IVD, kit, cell count
ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
NanoEnTek, Inc.
ADAM-rWBC
In Commercial Distribution

  • 08809317540252 ()
ADAM-rWBC

  • White blood cell count IVD, kit, cell count
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-MAYO
Not in Commercial Distribution

  • 10888234500728 ()
PAKAUTO-MAYO

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/II.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS100
Not in Commercial Distribution

  • 10888234500674 ()
PAKPLUS100

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution

  • 10888234500667 ()
EGEL48

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
403594
Not in Commercial Distribution

  • 10888234500650 ()
403594

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