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 the manufacturing changes to the dna synthesizer instrument platform for the vialed master mix and probe reagent components.
| Device | COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2011-12-12 |
| Decision Date | 2012-09-18 |
| PMA | P050028 |
| Supplement | S023 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |