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 changes to the manufacturing procedure for the bead coating process of the intermediate storage form of elecys coated microparticles.
| Device | ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 |
| 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 | 2011-08-29 |
| Decision Date | 2011-11-17 |
| PMA | P100032 |
| Supplement | S004 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 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 |