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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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GS - 00847865001922

Antibody to Hepatitis B Surface Antigen (Human) GS HBsAg 3.0 - HBsAg Confirmatory Assay 3.0
Bio-RAD Laboratories, Inc.
32594
In Commercial Distribution

  • 00847865001922 ()

  • 25 Tests
32594

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001892

HBsAg EIA 3.0 Low Positive Control, 8 mL
Bio-RAD Laboratories, Inc.
25110
In Commercial Distribution

  • 00847865001892 ()

  • Total Volume: 8 Milliliter
25110

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001885

HBsAg EIA 3.0 Positive Control, 8 mL
Bio-RAD Laboratories, Inc.
25109
In Commercial Distribution

  • 00847865001885 ()

  • Total Volume: 8 Milliliter
25109

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001878

HBsAg EIA 3.0 Negative Control, 12 mL
Bio-RAD Laboratories, Inc.
25108
In Commercial Distribution

  • 00847865001878 ()

  • Total Volume: 12 Milliliter
25108

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001854

HBsAg EIA 3.0 Conjugate Concentrate, 1.2 mL
Bio-RAD Laboratories, Inc.
25103
In Commercial Distribution

  • 00847865001854 ()

  • Total Volume: 1.2 Milliliter
25103

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001847

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 4800 Tests
Bio-RAD Laboratories, Inc.
25258
In Commercial Distribution

  • 00847865001847 ()

  • 4800 Tests
25258

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001830

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests
Bio-RAD Laboratories, Inc.
32592
In Commercial Distribution

  • 00847865001830 ()

  • 960 Tests
32592

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

GS - 00847865001823

Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 480 Tests
Bio-RAD Laboratories, Inc.
32591
In Commercial Distribution

  • 00847865001823 ()

  • 480 Tests
32591

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

Atellica™ IM HBsII QC - 00630414599281

HBsAgII (HBsII) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995605
In Commercial Distribution

  • 00630414599281 ()
10995605

  • Hepatitis B virus surface antigen IVD, control

Atellica™ IM HBsII - 00630414599274

HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995604
In Commercial Distribution

  • 00630414599274 ()
10995604

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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