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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)

IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC - 00630414978017

Anti-HBc IgM CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

IMMULITE®/IMMULITE®1000 Systems BcM Anti-HBc IgM - 00630414977720

BcM Anti-HBc IgM Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488615
Not in Commercial Distribution

  • 00630414977720 ()
LKMC1(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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