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.
Addition of negative samples in the final release qc test, and an addition of the raw material combination test in the manufacture of the conjugate reagent.
| Device | ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS |
| 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 | 2014-02-14 |
| Decision Date | 2014-03-10 |
| PMA | P000014 |
| Supplement | S027 |
| 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 |