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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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VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801425
In Commercial Distribution

  • 10758750002795 ()
6801425

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802452
In Commercial Distribution

  • 10758750002788 ()
6802452

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802451
In Commercial Distribution

  • 10758750002771 ()
6802451

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802450
In Commercial Distribution

  • 10758750002764 ()
6802450

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBs Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801926
In Commercial Distribution

  • 10758750001699 ()
  • 20758750001696 ()
6801926

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801925
In Commercial Distribution

  • 10758750001682 ()
  • 20758750001689 ()
6801925

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBeAg Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801820
In Commercial Distribution

  • 10758750001453 ()
  • 20758750001450 ()
6801820

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBeAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801819
In Commercial Distribution

  • 10758750001446 ()
  • 20758750001443 ()
6801819

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBe Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801817
In Commercial Distribution

  • 10758750001439 ()
  • 20758750001436 ()
6801817

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801816
In Commercial Distribution

  • 10758750001422 ()
  • 20758750001429 ()
6801816

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
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