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.
| Device | VITROS HBeAg Assays |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2023-01-24 |
| PMA | P090008 |
| Supplement | S023 |
| Product Code | MZO |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Revisions To The Package Insert To Include Information On Biotin Interference. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090008 | Original Filing | |
| S023 | 2022-09-30 | Real-time Process |
| S022 | ||
| S021 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S020 | 2018-04-17 | Real-time Process |
| S019 | 2017-10-11 | Real-time Process |
| S018 | 2017-08-03 | 30-day Notice |
| S017 | 2016-02-16 | 30-day Notice |
| S016 | 2016-01-27 | 30-day Notice |
| S015 | 2015-10-07 | 30-day Notice |
| S014 | 2014-08-22 | 30-day Notice |
| S013 | 2014-04-04 | Real-time Process |
| S012 | 2012-11-30 | 30-day Notice |
| S011 | 2012-09-05 | 30-day Notice |
| S010 | ||
| S009 | 2012-02-29 | 30-day Notice |
| S008 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S007 | 2011-11-21 | 30-day Notice |
| S006 | 2011-11-01 | Normal 180 Day Track |
| S005 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S004 | 2011-08-17 | 135 Review Track For 30-day Notice |
| S003 | 2011-05-17 | Normal 180 Day Track No User Fee |
| S002 | 2011-04-11 | 30-day Notice |
| S001 | 2010-07-28 | Normal 180 Day Track |