Approval for the migration of the vitros immunodiagnostic products hbeag reagent pack, calibrator, and controls to two additional systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS |
| 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 | 2016-12-02 |
| Decision Date | 2017-09-12 |
| PMA | P090028 |
| Supplement | S010 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P090028 | | Original Filing |
| S018 |
2022-09-30 |
Real-time Process |
| S017 |
2019-05-21 |
30-day Notice |
| S016 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S015 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S014 |
2018-02-12 |
30-day Notice |
| S013 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S012 | | |
| S011 |
2017-09-25 |
30-day Notice |
| S010 |
2016-12-02 |
Normal 180 Day Track |
| S009 |
2015-08-10 |
30-day Notice |
| S008 |
2015-06-25 |
30-day Notice |
| S007 |
2013-09-20 |
30-day Notice |
| S006 |
2012-11-29 |
30-day Notice |
| S005 |
2012-11-15 |
30-day Notice |
| S004 |
2012-10-17 |
30-day Notice |
| S003 |
2012-09-19 |
30-day Notice |
| S002 |
2012-03-22 |
30-day Notice |
| S001 |
2011-10-11 |
30-day Notice |
NIH GUDID Devices