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.
Change within the manufacturing site to increase production capacity for a component of the streptavidin- coated microparticles used in both of these assays.
| Device | ELECSYS ANTI-HBC IMMUNOASSAY |
| Classification Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2011-07-01 |
| Decision Date | 2011-07-22 |
| PMA | P100032 |
| Supplement | S001 |
| Product Code | LOM |
| 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 DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100032 | Original Filing | |
| S021 | 2021-09-30 | Normal 180 Day Track |
| S020 | 2018-10-26 | Normal 180 Day Track No User Fee |
| S019 | 2018-10-09 | 30-day Notice |
| S018 | 2018-03-01 | Real-time Process |
| S017 | 2017-10-11 | Real-time Process |
| S016 | 2017-08-03 | 30-day Notice |
| S015 | 2017-05-24 | 30-day Notice |
| S014 | 2017-02-21 | Normal 180 Day Track |
| S013 | 2016-02-16 | 30-day Notice |
| S012 | 2016-01-27 | 30-day Notice |
| S011 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S010 | 2015-10-07 | 30-day Notice |
| S009 | 2013-04-09 | Real-time Process |
| S008 | 2012-11-30 | 30-day Notice |
| S007 | 2012-09-04 | Normal 180 Day Track |
| S006 | 2012-02-29 | 30-day Notice |
| S005 | 2012-01-31 | 135 Review Track For 30-day Notice |
| S004 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S003 | 2011-08-17 | Normal 180 Day Track No User Fee |
| S002 | 2011-08-17 | 135 Review Track For 30-day Notice |
| S001 | 2011-07-01 | 30-day Notice |