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.
Approval for changes to your assay instrumentation and software platform collectively referred to as the cap/ctm second generation system.
| Device | ROCHE COBAS TAQMAN HBV TESTS |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2011-07-01 |
| Decision Date | 2012-03-20 |
| PMA | P050028 |
| Supplement | S020 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050028 | Original Filing | |
| S086 | 2022-10-21 | 30-day Notice |
| S085 | 2021-06-14 | 30-day Notice |
| S084 | 2021-02-23 | 30-day Notice |
| S083 | 2020-07-27 | 30-day Notice |
| S082 | 2020-04-17 | 30-day Notice |
| S081 | 2020-01-23 | 30-day Notice |
| 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 |