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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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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

Elecsys PreciControl HBsAg - 04015630911059

No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control

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 HBeAg - 04015630939862

No Description
Roche Diagnostics GmbH
07027427190
In Commercial Distribution

  • 04015630939862 ()
07027427190

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

Elecsys HBsAg II - 04015630939008

No Description
Roche Diagnostics GmbH
04687787160
Not in Commercial Distribution

  • 04015630939008 ()
04687787160

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

PreciControl Anti-HBe - 04015630938872

Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control

Elecsys Anti-HBe - 04015630938865

No Description
Roche Diagnostics GmbH
11820613160
In Commercial Distribution

  • 04015630938865 ()
11820613160

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

Elecsys HBeAg immunoassay - 04015630935215

No Description
Roche Diagnostics GmbH
11820583160
Not in Commercial Distribution

  • 04015630935215 ()
11820583160

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