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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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LIFECODES HLA-A SSO Typing Kit - 10888234400004

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628911
Not in Commercial Distribution

  • 10888234400004 ()
628911

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

N/A - 00382906579874

BD® HLA-B27 Application Module v2.0
BECTON, DICKINSON AND COMPANY
657987
Not in Commercial Distribution

  • 00382906579874 ()
657987

  • Laboratory instrument/analyser application software IVD

N/A - 00382906434388

BD® HLA-B27 Software v5.1
BECTON, DICKINSON AND COMPANY
643438
Not in Commercial Distribution

  • 00382906434388 ()
643438

  • Laboratory instrument/analyser application software IVD

N/A - 00382906407764

BD® HLA-B27 Application Module v1.0
BECTON, DICKINSON AND COMPANY
640776
Not in Commercial Distribution

  • 00382906407764 ()
640776

  • Laboratory instrument/analyser application software IVD

N/A - 00382903401833

HLA-B27 Kit Tests IVD
Becton, Dickinson And Company
340183
In Commercial Distribution

  • 00382903401833 ()
340183

  • White blood cell count IVD, kit, cell count

PE - Conjugated Goat Anti-Human IgG (100X) - 00812117019109

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117019109 ()
LSPSAB2

  • HLA class I & II antibody screening IVD, kit, multiplex

LABScreen™ Multi - Sample - 00812117018935

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018935 ()
LSMUTRS

  • HLA class I & II antibody screening IVD, kit, multiplex

LABScreen™ Mixed Class I & II - Sample - 00812117018928

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018928 ()
LSMS

  • HLA class I & II antibody screening IVD, kit, multiplex

LABScreen™ PRA Class II - Group 1 Sample - 00812117018898

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018898 ()
LS2PRAS

  • HLA class I & II antibody screening IVD, kit, multiplex

LABScreen™ Single Antigen HLA Class II Supplement - Group 1 - 00812117018881

LABScreen products are intended for use in detection of HLA antibody using flowcytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117018881 ()
LS2ASP01

  • HLA class I & II antibody screening IVD, kit, multiplex
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