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.
1) changing the timings of the qa release test from sequential to concurrent described as the single-test; and 2) reducing the number of the assays in the mgcc release test.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR |
| 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 | Ortho-Clinical Diagnostics, Inc. |
| Date Received | 2012-02-15 |
| Decision Date | 2012-03-13 |
| PMA | P000014 |
| Supplement | S025 |
| 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 | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000014 | Original Filing | |
| S036 | 2020-09-22 | 30-day Notice |
| S035 | 2019-05-21 | 30-day Notice |
| S034 | 2018-10-16 | Normal 180 Day Track No User Fee |
| S033 | 2018-02-21 | Normal 180 Day Track No User Fee |
| S032 | 2018-01-09 | Normal 180 Day Track No User Fee |
| S031 | 2015-08-10 | 30-day Notice |
| S030 | 2015-06-25 | 30-day Notice |
| S029 | 2015-06-24 | Normal 180 Day Track |
| S028 | 2014-11-14 | 30-day Notice |
| S027 | 2014-02-14 | 30-day Notice |
| S026 | 2012-10-17 | 30-day Notice |
| S025 | 2012-02-15 | 30-day Notice |
| S024 | 2011-10-05 | Real-time Process |
| S023 | 2011-02-14 | 30-day Notice |
| S022 | 2010-10-18 | 30-day Notice |
| S021 | 2010-07-27 | 30-day Notice |
| S020 | 2009-12-01 | Normal 180 Day Track No User Fee |
| S019 | 2009-09-04 | Normal 180 Day Track |
| S018 | 2009-03-06 | 30-day Notice |
| S017 | 2008-11-13 | Normal 180 Day Track No User Fee |
| S016 | 2008-01-23 | 30-day Notice |
| S015 | 2007-05-11 | 30-day Notice |
| S014 | 2006-05-12 | 30-day Notice |
| S013 | 2005-11-21 | 30-day Notice |
| S012 | 2005-05-09 | 30-day Notice |
| S011 | 2005-03-01 | 30-day Notice |
| S010 | 2004-10-26 | 30-day Notice |
| S009 | 2004-09-15 | Real-time Process |
| S008 | 2004-07-07 | 30-day Notice |
| S007 | 2004-05-05 | 30-day Notice |
| S006 | 2003-06-16 | 30-day Notice |
| S005 | 2003-01-30 | 30-day Notice |
| S004 | 2001-03-26 | Normal 180 Day Track |
| S003 | 2001-03-22 | 30-day Notice |
| S002 | 2001-03-12 | 135 Review Track For 30-day Notice |
| S001 | 2001-03-05 | 30-day Notice |