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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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MONOLISA™ - 00847865011365

MONOLISA™ Anti-HBc IgM EIA, 192 Tests
Bio-RAD Laboratories, Inc.
26174
In Commercial Distribution

  • 00847865011365 ()

  • 192 tests
26174

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

MONOLISA™ - 00847865002110

Anti-HBs EIA, Specimen Diluent 10 mL
Bio-RAD Laboratories, Inc.
26156
In Commercial Distribution

  • 00847865002110 ()

  • Total Volume: 10 Milliliter
26156

  • Hepatitis B virus surface total antibody IVD, reagent

MONOLISA™ - 00847865002097

Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL
Bio-RAD Laboratories, Inc.
26154
In Commercial Distribution

  • 00847865002097 ()

  • Total Volume: 1.8 Milliliter
26154

  • Hepatitis B virus surface total antibody IVD, calibrator

MONOLISA™ - 00847865002080

Anti-HBs EIA, Negative Control 1.5 mL
Bio-RAD Laboratories, Inc.
26153
In Commercial Distribution

  • 00847865002080 ()

  • Total Volume: 1.5 Milliliter
26153

  • Hepatitis B virus surface total antibody IVD, reagent

MONOLISA™ - 00847865002073

Anti-HBs EIA, Positive Control 1.5 mL
Bio-RAD Laboratories, Inc.
26152
In Commercial Distribution

  • 00847865002073 ()

  • Total Volume: 1.5 Milliliter
26152

  • Hepatitis B virus surface total antibody IVD, reagent

MONOLISA™ - 00847865002066

Anti-HBs EIA Hepatitis B Surface Antigen (Human) Horeseradish Peroxidase Conjugate
Bio-RAD Laboratories, Inc.
26151
In Commercial Distribution

  • 00847865002066 ()

  • Total Volume: 3 Milliliter
26151

  • Hepatitis B virus surface total antibody IVD, reagent

MONOLISA - 00847865002059

MONOLISA™ Anti-HBs EIA 192 tests
Bio-RAD Laboratories, Inc.
25220
In Commercial Distribution

  • 00847865002059 ()

  • 192 Tests
25220

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

MONOLISA™ - 00847865002042

MONOLISA™ Anti-HBs EIA Calibrator Kit
Bio-RAD Laboratories, Inc.
25219
In Commercial Distribution

  • 00847865002042 ()

  • 20 Tests
25219

  • Hepatitis B virus surface total antibody IVD, calibrator

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)
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