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 addition of the text “and then briefly mix (e. G. Vortex for 3-5 seconds)” and other minor revisions to the ifu labeling.
| Device | COBAS HBV |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2016-11-22 |
| Decision Date | 2016-12-19 |
| PMA | P150014 |
| Supplement | S006 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| 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 |