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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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No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
11876317160
Not in Commercial Distribution

  • 04015630910908 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 04015630999286 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
07251076190
Not in Commercial Distribution

  • 04015630940028 ()
07251076190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04687787160
Not in Commercial Distribution

  • 04015630939008 ()
04687787160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control
No Description
Roche Diagnostics GmbH
11820613160
In Commercial Distribution

  • 04015630938865 ()
11820613160

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820583160
Not in Commercial Distribution

  • 04015630935215 ()
11820583160

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876376160
Not in Commercial Distribution

  • 04015630934843 ()
11876376160

  • Hepatitis B virus e-antigen IVD, control
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