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.
Update of the calibration test definition file (tdf) used in the production of the cobas ampliprep/cobas taqman hcv test and cobas taqman hcv test version 2. 0 for use with the high pure system.
| Device | COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 |
| 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 | 2014-02-03 |
| Decision Date | 2014-03-04 |
| PMA | P060030 |
| Supplement | S039 |
| 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 |
|---|---|---|
| P060030 | Original Filing | |
| S086 | 2021-06-14 | 30-day Notice |
| S085 | 2021-02-23 | 30-day Notice |
| S084 | 2020-07-27 | 30-day Notice |
| S083 | 2020-04-17 | 30-day Notice |
| S082 | 2020-01-23 | 30-day Notice |
| S081 | 2019-10-08 | 30-day Notice |
| S080 | 2019-09-20 | 30-day Notice |
| S079 | 2019-08-16 | 30-day Notice |
| S078 | 2019-07-15 | Special (immediate Track) |
| S077 | 2019-05-23 | Real-time Process |
| S076 | 2019-04-24 | 30-day Notice |
| S075 | 2019-04-10 | 30-day Notice |
| S074 | 2019-04-08 | 30-day Notice |
| S073 | 2019-03-20 | 30-day Notice |
| S072 | 2018-12-14 | 30-day Notice |
| S071 | 2018-11-13 | 30-day Notice |
| S070 | 2018-11-09 | 30-day Notice |
| S069 | 2018-08-21 | 30-day Notice |
| S068 | 2018-07-27 | 30-day Notice |
| S067 | 2018-06-29 | 30-day Notice |
| S066 | 2018-06-08 | 30-day Notice |
| S065 | 2018-06-04 | 30-day Notice |
| S064 | 2018-04-16 | 30-day Notice |
| S063 | 2018-04-16 | 30-day Notice |
| S062 | 2018-03-01 | 30-day Notice |
| S061 | 2017-11-14 | 30-day Notice |
| S060 | 2017-09-26 | 30-day Notice |
| S059 | 2017-08-07 | 30-day Notice |
| S058 | 2017-07-14 | 30-day Notice |
| S057 | 2017-07-14 | 30-day Notice |
| S056 | 2017-04-21 | Special (immediate Track) |
| S055 | 2016-09-22 | 30-day Notice |
| S054 | 2016-08-16 | 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 | 2015-11-17 | Real-time Process |
| S048 | 2015-08-31 | Normal 180 Day Track |
| S047 | 2015-04-09 | 30-day Notice |
| S046 | 2015-03-13 | 30-day Notice |
| S045 | 2015-02-25 | Real-time Process |
| S044 | 2014-12-19 | 30-day Notice |
| S043 | 2014-07-28 | 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 | 2014-02-03 | 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 | 2013-07-26 | 30-day Notice |
| S032 | 2013-05-09 | 30-day Notice |
| S031 | 2012-11-16 | Real-time Process |
| S030 | 2012-11-06 | Real-time Process |
| S029 | 2012-09-13 | 30-day Notice |
| S028 | 2012-08-15 | 30-day Notice |
| S027 | 2012-07-02 | Normal 180 Day Track |
| S026 | 2012-05-30 | Real-time Process |
| S025 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S024 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S023 | 2011-09-12 | 30-day Notice |
| S022 | 2011-08-24 | 30-day Notice |
| S021 | 2011-07-01 | Normal 180 Day Track |
| S020 | 2011-05-31 | Normal 180 Day Track No User Fee |
| S019 | ||
| S018 | 2011-04-07 | Special (immediate Track) |
| S017 | 2011-03-01 | 30-day Notice |
| S016 | 2011-03-01 | 135 Review Track For 30-day Notice |
| S015 | 2011-02-08 | 30-day Notice |
| S014 | 2010-08-25 | 30-day Notice |
| S013 | ||
| S012 | 2010-08-05 | 30-day Notice |
| S011 | ||
| S010 | 2010-05-03 | 30-day Notice |
| S009 | 2010-03-01 | 30-day Notice |
| S008 | 2010-01-08 | 30-day Notice |
| S007 | 2009-12-24 | 30-day Notice |
| S006 | 2009-12-22 | Normal 180 Day Track |
| S005 | 2009-09-15 | 30-day Notice |
| S004 | 2009-07-02 | 30-day Notice |
| S003 | 2009-04-28 | 30-day Notice |
| S002 | 2008-12-05 | 30-day Notice |
| S001 | 2008-11-14 | 30-day Notice |