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.
| Device | VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-30 |
| Decision Date | 2023-01-24 |
| PMA | P100001 |
| Supplement | S017 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORTHO-CLINICAL DIAGNOSTICS 100 Indigo Creek Dr. rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Revisions To The Package Insert To Include Information On Biotin Interference. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100001 | Original Filing | |
| S017 | 2022-09-30 | Real-time Process |
| S016 | 2019-05-21 | 30-day Notice |
| S015 | 2018-10-16 | Normal 180 Day Track No User Fee |
| S014 | 2018-02-21 | Normal 180 Day Track No User Fee |
| S013 | 2018-01-25 | 30-day Notice |
| S012 | 2018-01-09 | Normal 180 Day Track No User Fee |
| S011 | 2017-08-28 | 30-day Notice |
| S010 | 2016-11-17 | Normal 180 Day Track |
| S009 | 2016-09-12 | 30-day Notice |
| S008 | 2015-08-10 | 30-day Notice |
| S007 | 2015-06-25 | 30-day Notice |
| S006 | 2013-09-20 | 30-day Notice |
| S005 | 2012-11-29 | 30-day Notice |
| S004 | 2012-10-26 | 30-day Notice |
| S003 | 2012-10-17 | 30-day Notice |
| S002 | 2012-09-19 | 30-day Notice |
| S001 | 2012-03-22 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 10758750001439 | P100001 | 006 |
| 10758750001422 | P100001 | 006 |