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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 - 10758750001217

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801428
In Commercial Distribution

  • 10758750001217 ()
  • 20758750001214 ()
6801428

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

VITROS - 10758750001194

VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801426
In Commercial Distribution

  • 10758750001194 ()
6801426

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

VITROS - 10758750001187

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

  • 10758750001187 ()
6801425

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

VITROS - 10758750001088

VITROS Immunodiagnostic Products HBsAg Confirmatory Kit
ORTHO CLINICAL DIAGNOSTICS
6801324
In Commercial Distribution

  • 10758750001088 ()
  • 20758750001085 ()
6801324

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001071

VITROS Immunodiagnostic Products HBsAg Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801323
In Commercial Distribution

  • 10758750001071 ()
  • 20758750001078 ()
6801323

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001064

VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801322
In Commercial Distribution

  • 10758750001064 ()
  • 20758750001061 ()
6801322

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Elecsys Anti-HBs Immunoassay - 04015630919420

No Description
Roche Diagnostics GmbH
11820524160
Not in Commercial Distribution

  • 04015630919420 ()
11820524160

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

Elecsys PreciControl Anti-HBc IgM - 04015630911622

No Description
Roche Diagnostics GmbH
11876333160
Not in Commercial Distribution

  • 04015630911622 ()
11876333160

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

Elecsys Anti-HBc IgM Immunoassay - 04015630911615

No Description
Roche Diagnostics GmbH
11820567160
Not in Commercial Distribution

  • 04015630911615 ()
11820567160

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

Elecsys HBsAg Immunoassay - 04015630911073

No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
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