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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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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)
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)
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)
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)
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)
Anti-HBs2 (aHBs2) QC Kit - Atellica IM - CLT 2 x 2 x 10.0 mL
Siemens Healthcare Diagnostics Inc.
10995454
In Commercial Distribution

  • 00630414597843 ()
10995454

  • Hepatitis B virus surface total antibody IVD, control
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995453
In Commercial Distribution

  • 00630414597836 ()
10995453

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995450
In Commercial Distribution

  • 00630414597805 ()
10995450

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995449
In Commercial Distribution

  • 00630414597799 ()
10995449

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10698706
In Commercial Distribution

  • 00630414591407 ()
10698706

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
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