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.
Removal of an upper test limit specification of a curve-shape parameter in an in-process quality control functionality test.
| Device | VITROS IMMUNODIAGNOSTIC ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS 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 | 2014-11-14 |
| Decision Date | 2014-12-11 |
| PMA | P000014 |
| Supplement | S028 |
| 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 |