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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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Hepatitis B Virus Surface Antigen Control Slides
BIO SB, INC.
BSB-9208-CS
In Commercial Distribution

  • B502BSB9208CS0 ()
BSB-9208-CS

  • Hepatitis B virus surface antigen IVD, control
Hepatitis B Virus Core Antigen Control Slides
BIO SB, INC.
BSB-9207-CS
In Commercial Distribution

  • B502BSB9207CS0 ()
BSB-9207-CS

  • Hepatitis B virus core 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
No Description
Roche Diagnostics GmbH
08741107162
In Commercial Distribution

  • 07613336183236 ()
08741107162

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
04687876162
In Commercial Distribution

  • 07613336183168 ()
04687876162

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
08821976190
In Commercial Distribution

  • 07613336166345 ()
08821976190

  • Amyloid B component IVD, calibrator
No Description
FUJIREBIO INC.
234891
In Commercial Distribution

  • 04987270234891 ()

  • Number of bottles per kit: 7
  • Total mLs per bottle: 10


  • Amyloid B component IVD, calibrator
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