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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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ARCHITECT HBsAg Next Qualitative Controls
Abbott Ireland Diagnostics
4P76-12
In Commercial Distribution

  • 00380740208462 ()
04P7612

  • Hepatitis B virus surface antigen IVD, control
Alinity i Anti-HBs Reagent Kit (1200T)
Abbott Ireland Diagnostics
07P8857
In Commercial Distribution

  • 00380740173562 ()
07P8857

  • Hepatitis B virus surface total antibody IVD, reagent
Alinity i Anti-HBs Reagent Kit (200T)
Abbott Ireland Diagnostics
07P8852
In Commercial Distribution

  • 00380740173555 ()
07P8852

  • Hepatitis B virus surface total antibody IVD, reagent
ARCHITECT AUSAB Reagent Kit (500T)
Abbott Ireland Diagnostics
01L8238
In Commercial Distribution

  • 00380740171759 ()
01L8238

  • Hepatitis B virus surface total antibody IVD, reagent
ARCHITECT AUSAB Reagent Kit (100T)
Abbott Ireland Diagnostics
01L8228
In Commercial Distribution

  • 00380740171742 ()
01L8228

  • Hepatitis B virus surface total antibody IVD, reagent
ARCHITECT HBsAg Next Qualitative Reagent Kit (2000T)
Abbott Ireland Diagnostics
4P76-32
In Commercial Distribution

  • 00380740163389 ()
04P7632

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26203
In Commercial Distribution

  • 00847865013178 ()

  • Total Volume: 1.5 Milliliter
26203

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control
Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL
Bio-RAD Laboratories, Inc.
26202
In Commercial Distribution

  • 00847865013161 ()

  • Total Volume: 7.5 Milliliter
26202

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc IgM EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26201
In Commercial Distribution

  • 00847865013154 ()

  • Total Volume: 0.8 Milliliter
26201

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Positive Control,1.6 mL
Bio-RAD Laboratories, Inc.
26200
In Commercial Distribution

  • 00847865013147 ()

  • Total Volume: 1.6 Milliliter
26200

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26199
In Commercial Distribution

  • 00847865013130 ()

  • Total Volume: 30 Milliliter
26199

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc IgM EIA Conjugate Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26198
In Commercial Distribution

  • 00847865013123 ()

  • Total Volume: 30 Milliliter
26198

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26197
In Commercial Distribution

  • 00847865013116 ()

  • Total Volume: 0.8 Milliliter
26197

  • Hepatitis B virus core antigen IVD, control
Anti-HBc EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26196
In Commercial Distribution

  • 00847865013109 ()

  • Total Volume: 30 Milliliter
26196

  • Hepatitis B virus core antigen IVD, reagent
Anti-HBc EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26195
In Commercial Distribution

  • 00847865013093 ()

  • Total Volume: 1.5 Milliliter
26195

  • Hepatitis B virus core total antibody IVD, calibrator
Anti-HBc EIA, Positive Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26194
In Commercial Distribution

  • 00847865013086 ()

  • Total Volume: 0.8 Milliliter
26194

  • Hepatitis B virus core antigen IVD, control
Anti-HBc EIA, Conjugate Reagent 30 mL
Bio-RAD Laboratories, Inc.
26193
In Commercial Distribution

  • 00847865013079 ()

  • Total Volume: 30 Milliliter
26193

  • Hepatitis B virus core antigen IVD, reagent
MONOLISA™ Anti-HBc EIA 192 Tests
Bio-RAD Laboratories, Inc.
26186
In Commercial Distribution

  • 00847865011372 ()

  • 192 tests
26186

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