COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Premarket Approval P050028 S080

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Change of a supplier's manufacturing site for critical components

DeviceCOBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
Classification NameHepatitis Viral B Dna Detection
Generic NameHepatitis Viral B Dna Detection
ApplicantRoche Molecular Systems, Inc.
Date Received2019-10-08
Decision Date2019-11-05
PMAP050028
SupplementS080
Product CodeMKT
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722

Supplemental Filings

Supplement NumberDateSupplement Type
P050028Original Filing
S080 2019-10-08 30-day Notice
S079 2019-09-20 30-day Notice
S078 2019-08-16 30-day Notice
S077 2019-07-15 Special (immediate Track)
S076 2019-04-24 30-day Notice
S075 2019-04-08 30-day Notice
S074 2019-03-20 30-day Notice
S073 2018-12-14 30-day Notice
S072 2018-11-13 30-day Notice
S071 2018-11-09 30-day Notice
S070 2018-08-21 30-day Notice
S069 2018-07-27 30-day Notice
S068 2018-06-29 30-day Notice
S067 2018-06-08 30-day Notice
S066 2018-06-04 30-day Notice
S065 2018-05-21 30-day Notice
S064 2018-04-16 30-day Notice
S063 2018-04-16 30-day Notice
S062 2018-04-16 30-day Notice
S061 2018-03-01 30-day Notice
S060 2017-11-14 30-day Notice
S059 2017-10-30 30-day Notice
S058 2017-09-26 30-day Notice
S057 2017-07-14 30-day Notice
S056 2017-07-14 30-day Notice
S055 2017-04-21 Special (immediate Track)
S054 2016-09-22 30-day Notice
S053 2016-07-19 30-day Notice
S052 2016-07-08 30-day Notice
S051 2016-04-18 30-day Notice
S050 2016-04-07 30-day Notice
S049
S048 2015-11-17 Real-time Process
S047 2015-06-24 30-day Notice
S046 2015-04-09 30-day Notice
S045 2015-03-13 30-day Notice
S044 2015-02-25 Real-time Process
S043 2014-12-19 30-day Notice
S042 2014-03-31 30-day Notice
S041 2014-03-18 30-day Notice
S040 2014-02-18 30-day Notice
S039 2013-12-26 30-day Notice
S038 2013-12-13 30-day Notice
S037 2013-09-09 30-day Notice
S036 2013-09-09 30-day Notice
S035 2013-08-14 30-day Notice
S034 2013-08-09 30-day Notice
S033 2013-05-28 30-day Notice
S032 2013-05-09 30-day Notice
S031 2013-04-08 30-day Notice
S030 2013-02-19 Real-time Process
S029 2012-11-16 Real-time Process
S028 2012-11-06 Real-time Process
S027 2012-09-13 30-day Notice
S026 2012-08-15 30-day Notice
S025 2012-05-30 Real-time Process
S024 2012-03-29 Normal 180 Day Track No User Fee
S023 2011-12-12 135 Review Track For 30-day Notice
S022 2011-09-12 30-day Notice
S021 2011-09-01 Special (immediate Track)
S020 2011-07-01 Normal 180 Day Track
S019 2011-05-31 Normal 180 Day Track No User Fee
S018
S017 2011-03-08 135 Review Track For 30-day Notice
S016 2011-03-01 30-day Notice
S015 2011-03-01 135 Review Track For 30-day Notice
S014
S013 2011-02-08 30-day Notice
S012 2010-11-08 30-day Notice
S011 2010-09-22 135 Review Track For 30-day Notice
S010
S009
S008 2010-08-05 30-day Notice
S007 2010-01-08 30-day Notice
S006 2009-12-24 30-day Notice
S005 2009-07-02 30-day Notice
S004 2009-07-01 Normal 180 Day Track
S003 2008-12-05 30-day Notice
S002 2008-10-31 30-day Notice
S001 2008-10-06 Real-time Process

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