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 an instruction to the labeling to visually inspect reagent cassette and vial prior to use.
| Device | cobas AmpliPrep/cobas TaqMan CMV Test |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2019-07-15 |
| Decision Date | 2019-08-13 |
| PMA | P110037 |
| Supplement | S048 |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110037 | Original Filing | |
| S057 | 2022-10-21 | 30-day Notice |
| S056 | 2021-06-14 | 30-day Notice |
| S055 | 2021-02-23 | 30-day Notice |
| S054 | 2020-07-27 | 30-day Notice |
| S053 | 2020-04-17 | 30-day Notice |
| S052 | 2020-01-23 | 30-day Notice |
| S051 | 2019-10-08 | 30-day Notice |
| S050 | 2019-09-20 | 30-day Notice |
| S049 | 2019-08-16 | 30-day Notice |
| S048 | 2019-07-15 | Special (immediate Track) |
| S047 | 2019-04-24 | 30-day Notice |
| S046 | 2019-04-10 | 30-day Notice |
| S045 | 2019-03-20 | 30-day Notice |
| S044 | 2018-12-14 | 30-day Notice |
| S043 | 2018-11-13 | 30-day Notice |
| S042 | 2018-11-09 | 30-day Notice |
| S041 | 2018-08-21 | 30-day Notice |
| S040 | 2018-07-27 | 30-day Notice |
| S039 | 2018-06-29 | 30-day Notice |
| S038 | 2018-06-08 | 30-day Notice |
| S037 | 2018-06-04 | 30-day Notice |
| S036 | 2018-04-16 | 30-day Notice |
| S035 | 2018-04-16 | 30-day Notice |
| S034 | 2018-03-01 | 30-day Notice |
| S033 | 2017-11-14 | 30-day Notice |
| S032 | 2017-09-26 | 30-day Notice |
| S031 | 2017-07-14 | 30-day Notice |
| S030 | 2017-07-14 | 30-day Notice |
| S029 | 2016-09-22 | 30-day Notice |
| S028 | 2016-07-19 | 30-day Notice |
| S027 | 2016-07-08 | 30-day Notice |
| S026 | 2016-04-18 | 30-day Notice |
| S025 | 2016-04-07 | 30-day Notice |
| S024 | 2015-11-17 | Real-time Process |
| S023 | 2015-10-22 | Normal 180 Day Track |
| S022 | 2015-06-24 | 30-day Notice |
| S021 | 2015-04-09 | 30-day Notice |
| S020 | 2015-03-13 | 30-day Notice |
| S019 | 2015-02-25 | Real-time Process |
| S018 | 2014-12-19 | 30-day Notice |
| S017 | 2014-12-19 | 30-day Notice |
| S016 | 2014-12-16 | Real-time Process |
| S015 | 2014-03-31 | 30-day Notice |
| S014 | 2014-03-18 | 30-day Notice |
| S013 | 2014-02-18 | 30-day Notice |
| S012 | 2013-10-30 | 30-day Notice |
| S011 | 2013-09-09 | 30-day Notice |
| S010 | 2013-09-09 | 30-day Notice |
| S009 | 2013-08-14 | 30-day Notice |
| S008 | 2013-08-09 | 30-day Notice |
| S007 | 2013-07-26 | 30-day Notice |
| S006 | 2013-05-09 | 30-day Notice |
| S005 | 2013-02-19 | Special (immediate Track) |
| S004 | 2012-11-16 | Real-time Process |
| S003 | 2012-11-02 | Real-time Process |
| S002 | 2012-08-15 | 30-day Notice |
| S001 | 2012-08-07 | Real-time Process |