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 HCV Test |
| Classification Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Generic Name | Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2017-09-27 |
| Decision Date | 2017-10-26 |
| PMA | P150015 |
| Supplement | S009 |
| Product Code | MZP |
| 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 |
|---|---|---|
| P150015 | Original Filing | |
| S043 | 2021-05-18 | Special (immediate Track) |
| S042 | 2020-11-13 | 30-day Notice |
| S041 | 2020-09-17 | Special (immediate Track) |
| S040 | 2020-07-27 | 30-day Notice |
| S039 | ||
| S038 | 2020-04-17 | 30-day Notice |
| S037 | 2020-01-10 | 30-day Notice |
| S036 | 2019-11-29 | 30-day Notice |
| S035 | 2019-09-20 | 30-day Notice |
| S034 | 2019-08-30 | 30-day Notice |
| S033 | 2019-08-06 | 30-day Notice |
| S032 | ||
| S031 | 2019-05-09 | 30-day Notice |
| S030 | 2019-05-09 | 30-day Notice |
| S029 | 2019-04-24 | 30-day Notice |
| S028 | 2019-04-24 | 30-day Notice |
| S027 | 2019-04-10 | 30-day Notice |
| S026 | 2019-04-08 | 30-day Notice |
| S025 | 2019-04-03 | 30-day Notice |
| S024 | 2019-03-27 | 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 | ||
| S018 | 2018-07-27 | 30-day Notice |
| S017 | 2018-06-29 | 30-day Notice |
| S016 | 2018-06-08 | 30-day Notice |
| S015 | 2018-06-04 | 30-day Notice |
| S014 | 2018-04-16 | 30-day Notice |
| S013 | 2018-03-01 | 30-day Notice |
| S012 | 2018-01-23 | 30-day Notice |
| S011 | 2017-11-22 | 30-day Notice |
| S010 | 2017-10-30 | 30-day Notice |
| S009 | 2017-09-27 | 30-day Notice |
| S008 | 2017-09-26 | 30-day Notice |
| S007 | 2017-07-14 | 30-day Notice |
| S006 | 2017-05-09 | 30-day Notice |
| S005 | 2016-11-22 | Special (immediate 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 |