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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
DIASORIN S.P.A.
318251
In Commercial Distribution

  • 28056771500214 ()
  • 08056771500210 ()


  • Hepatitis B virus surface antigen IVD, control
No Description
DIASORIN SPA
318150
In Commercial Distribution

  • 18056771103401 ()
  • 08056771103404 ()


  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0098
In Commercial Distribution

  • 00816784020604 ()
2020-0098

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
Lgc Clinical Diagnostics, Inc.
2020-0096
In Commercial Distribution

  • 00816784020598 ()
2020-0096

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
Lgc Clinical Diagnostics, Inc.
2020-0095
In Commercial Distribution

  • 00816784020581 ()
2020-0095

  • Hepatitis B virus nucleic acid IVD, control
ACCURUN 125 Anti-HBs 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0078
In Commercial Distribution

  • 00816784020352 ()
2015-0078

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
09366717190
In Commercial Distribution

  • 07613336182994 ()
09366717190

  • Hepatitis B virus surface antigen IVD, control
HBV High Run Control
EXACT DIAGNOSTICS, LLC
HBVH102
In Commercial Distribution

  • 00812242030130 ()
HBVH102

  • Hepatitis B virus nucleic acid IVD, control
HBV Low Run Control
EXACT DIAGNOSTICS, LLC
HBVL101
In Commercial Distribution

  • 00812242030123 ()
HBVL101

  • Hepatitis B virus nucleic acid IVD, control
HBV LOD
EXACT DIAGNOSTICS, LLC
HBVLOD
In Commercial Distribution

  • 00812242030703 ()
HBVLOD

  • Hepatitis B virus nucleic acid IVD, control
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