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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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ARK™ Methotrexate Assay - 00812101030639

The ARK Methotrexate Assay c-Pack (cobas c pack green reagent packs) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-03
In Commercial Distribution

  • 00812101030639 ()
5026-0001-03

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ABC SSPtray - 07611969953318

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)

ABDR SSPtray - 07611969953301

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)

DQB SSP Kit - 07611969953295

Kit for 24 determinations of HLA-DQB alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826220
Not in Commercial Distribution

  • 07611969953295 ()
826220

  • HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

DRB SSP Kit - 07611969953288

Kit for 24 determinations of HLA-DRB alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826215
Not in Commercial Distribution

  • 07611969953288 ()
826215

  • HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

HLA-C SSP Kit - 07611969953271

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)

HLA-B SSP Kit - 07611969953264

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)

HLA-A SSP Kit - 07611969953257

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)

Control-HLA-DR (pos.) - 07611969953196

Control-HLA-DR (pos.) (lyo.) 0,5 ml For use in the microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
824110
Not in Commercial Distribution

  • 07611969953196 ()
824110

  • HLA class I & II antigen tissue typing IVD, control

Control-HLA (neg.) - 07611969953189

Control-HLA (neg.) (lyo.) 0,5 ml For use in the microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
824106
Not in Commercial Distribution

  • 07611969953189 ()
824106

  • HLA class I & II antigen tissue typing IVD, control
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