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Panels › Microbiology › Product code MKT · Class 2

Hepatitis Viral B Dna Detection

Regulation 866.3174

0510(k)s in 12 months (0 all time)
0recalls in 12 months (7 all time)
2recalls that name a 510(k)
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Top companies in MKT

Company510(k)sRecalls
Abbott Molecular03
Medtronic Emergency Response Systems, Inc.01
Roche Diagnostics Operations, Inc.01
Roche Molecular Systems, Inc.01
Zoll Medical Corporation01
DateFirm and productCodeLinked 510(k)
Apr 6, 2022Abbott Molecular, Inc.
Alinity m HBV AMP Kit (US and CE)
Open, Classified		 MKTNone listed
Apr 6, 2022Abbott Molecular, Inc.
Alinity m HBV Application Specification File (US and CE)
Open, Classified		 MKTNone listed
Jul 15, 2016Roche Diagnostics Operations, Inc.
cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and
Terminated		 MKTNone listed
Mar 1, 2011Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
Terminated		 MKTNone listed
Feb 23, 2011Abbott Molecular
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantit
Terminated		 MKTNone listed
Aug 4, 2007Medtronic Emergency Response Systems, Inc.
biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguo
Terminated		 MKTK955854
Sep 17, 2004Zoll Medical Corporation
Zoll M Series Automated Defibrillator (AED)
Terminated		 MKTK010257

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