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.
Increase the scale of bulk and vialing manufacturing processes and to change filling lines for reagent component vialing.
| Device | cobas HBV Test |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2017-09-27 |
| Decision Date | 2017-10-26 |
| PMA | P150014 |
| Supplement | S010 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | 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 |
|---|---|---|
| P150014 | Original Filing | |
| S042 | 2021-12-20 | 30-day Notice |
| S041 | 2021-05-18 | Special (immediate Track) |
| S040 | 2020-11-13 | 30-day Notice |
| S039 | 2020-09-17 | Special (immediate Track) |
| S038 | 2020-07-27 | 30-day Notice |
| S037 | ||
| S036 | 2020-04-17 | 30-day Notice |
| S035 | 2020-01-10 | 30-day Notice |
| S034 | 2019-11-29 | 30-day Notice |
| S033 | 2019-09-20 | 30-day Notice |
| S032 | 2019-08-30 | 30-day Notice |
| S031 | 2019-08-06 | 30-day Notice |
| S030 | ||
| S029 | 2019-05-09 | 30-day Notice |
| S028 | 2019-05-09 | 30-day Notice |
| S027 | 2019-04-24 | 30-day Notice |
| S026 | 2019-04-24 | 30-day Notice |
| S025 | 2019-04-10 | 30-day Notice |
| S024 | 2019-04-03 | 30-day Notice |
| S023 | 2018-12-14 | 30-day Notice |
| S022 | 2018-11-13 | 30-day Notice |
| S021 | 2018-11-09 | 30-day Notice |
| S020 | 2018-08-21 | 30-day Notice |
| S019 | 2018-07-27 | 30-day Notice |
| S018 | 2018-06-29 | 30-day Notice |
| S017 | 2018-06-08 | 30-day Notice |
| S016 | 2018-06-04 | 30-day Notice |
| S015 | 2018-04-16 | 30-day Notice |
| S014 | 2018-03-01 | 30-day Notice |
| S013 | 2018-01-23 | 30-day Notice |
| S012 | 2017-11-22 | 30-day Notice |
| S011 | 2017-10-30 | 30-day Notice |
| S010 | 2017-09-27 | 30-day Notice |
| S009 | 2017-09-26 | 30-day Notice |
| S008 | 2017-07-14 | 30-day Notice |
| S007 | 2017-05-09 | 30-day Notice |
| S006 | 2016-11-22 | Special (immediate Track) |
| S005 | 2016-08-08 | Normal 180 Day Track |
| S004 | 2016-08-08 | Real-time Process |
| S003 | 2016-07-08 | 30-day Notice |
| S002 | 2016-04-07 | 30-day Notice |
| S001 | 2016-02-26 | 30-day Notice |