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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for 24 determinations of HLA-ABC alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826240
Not in Commercial Distribution

  • 07611969953318 ()
826240

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
Kit for 24 determinations of HLA-C alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826212
Not in Commercial Distribution

  • 07611969953271 ()
826212

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
for 24 determinations of HLA-B alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826206
Not in Commercial Distribution

  • 07611969953264 ()
826206

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
for 24 determinations of HLA-A alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826201
Not in Commercial Distribution

  • 07611969953257 ()
826201

  • HLA class I antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
DSI+II
In Commercial Distribution

  • 10888234500193 ()
DSI+II

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
303456
In Commercial Distribution

  • 10888234500186 ()
303456

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
Flexible Fabric Antibacterial Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
950987
In Commercial Distribution

  • 00050428280201 ()
  • 10050428280208 ()


  • Skin-cover adhesive strip, antimicrobial
Flexible Fabric Antibacterial Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
950987
In Commercial Distribution

  • 10050428269623 ()
  • 00050428269626 ()


  • Skin-cover adhesive strip, antimicrobial
for 24 determinations of HLA-ABDR alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826230
Not in Commercial Distribution

  • 07611969953301 ()
826230

  • HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
For Use with DonorScreen-HLA Class I and Class II
IMMUCOR GTI DIAGNOSTICS, INC.
404563
In Commercial Distribution

  • 10888234500483 ()
404563

  • HLA class I & II antibody screening IVD, reagent
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