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.
Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
| Device | ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER |
| 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 | 2016-02-16 |
| Decision Date | 2016-03-16 |
| PMA | P100032 |
| Supplement | S013 |
| 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 |