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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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Atellica IM HBeAg - 00630414301310

Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
11207281
In Commercial Distribution

  • 00630414301310 ()
11207281

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

Atellica IM HBcT - 00630414301303

HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207276
In Commercial Distribution

  • 00630414301303 ()
11207276

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

Atellica IM aHBs2 - 00630414301273

Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

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

Atellica IM aHBcM - 00630414301266

HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

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

VITROS - 10758750002788

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 - 10758750001453

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 - 10758750001446

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 - 10758750001439

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 - 10758750001422

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

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
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