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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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cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System - 00875197004885

No Description
Roche Diagnostics GmbH
07000979190
In Commercial Distribution

  • 00875197004885 ()
07000979190

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems - 00875197004717

No Description
Roche Diagnostics GmbH
06998836190
In Commercial Distribution

  • 00875197004717 ()
06998836190

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0 - 00875197002706

No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution

  • 00875197002706 ()
05027012190

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

COBAS® TaqMan® HBV Test, For Use With The High Pure System - 00875197002003

No Description
Roche Molecular Systems, Inc.
03577163190
In Commercial Distribution

  • 00875197002003 ()
03577163190

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

cobas® HBV - 00875197006414

No Description
Roche Molecular Systems, Inc.
09040820190
In Commercial Distribution

  • 00875197006414 ()
09040820190

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

COBAS® AmpliPrep / COBAS® TaqMan® Wash Reagent - 00875197002034

No Description
Roche Molecular Systems, Inc.
03587797190
In Commercial Distribution

  • 00875197002034 ()
03587797190

  • Buffered wash solution IVD

DOCKING STATION SHORT - 04015630936557

No Description
Roche Molecular Systems, Inc.
28127387001
In Commercial Distribution

  • 04015630936557 ()
28127387001

  • Nucleic acid sample preparation instrument IVD

High Pure System Viral Nucleic Acid Kit - 04038377020556

No Description
Roche Molecular Systems, Inc.
03502295001
In Commercial Distribution

  • 04038377020556 ()
03502295001

  • Nucleic acid extraction/isolation kit IVD

Aptima® - 15420045506770

Aptima® HBV Quant Assay Target Enhancer Reagent.
Hologic, Inc.
KIT, TER, HBV, VL, 100T, US IVD
In Commercial Distribution

  • 15420045506770 ()
PRD-04081

  • HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent

Aptima® - 15420045506749

The Aptima® HBV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system.
Hologic, Inc.
KIT, MAIN ASSAY, HBV, VL, 100T, US IVD
In Commercial Distribution

  • 15420045506749 ()
ASY-10269

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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