Approval for scaling up of a conjugate manufacturing process from 10mg to 96 mg.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & 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 | 2011-05-16 |
| Decision Date | 2011-09-27 |
| PMA | P030026 |
| Supplement | S022 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030026 | | Original Filing |
| S037 |
2022-09-30 |
Real-time Process |
| S036 |
2019-05-21 |
30-day Notice |
| S035 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S034 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S033 |
2018-01-16 |
30-day Notice |
| S032 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S031 |
2015-10-05 |
30-day Notice |
| S030 |
2015-08-10 |
30-day Notice |
| S029 |
2015-01-16 |
30-day Notice |
| S028 |
2013-09-20 |
30-day Notice |
| S027 |
2012-11-29 |
30-day Notice |
| S026 |
2012-10-17 |
30-day Notice |
| S025 |
2012-01-30 |
30-day Notice |
| S024 |
2011-10-05 |
Real-time Process |
| S023 |
2011-05-19 |
30-day Notice |
| S022 |
2011-05-16 |
135 Review Track For 30-day Notice |
| S021 |
2010-12-08 |
30-day Notice |
| S020 |
2010-10-18 |
30-day Notice |
| S019 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S018 |
2009-05-22 |
30-day Notice |
| S017 |
2009-03-06 |
30-day Notice |
| S016 |
2009-02-20 |
Normal 180 Day Track |
| S015 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S014 |
2008-02-27 |
30-day Notice |
| S013 |
2007-03-08 |
30-day Notice |
| S012 |
2007-02-07 |
Special (immediate Track) |
| S011 |
2006-08-21 |
30-day Notice |
| S010 |
2006-05-17 |
30-day Notice |
| S009 |
2005-11-14 |
30-day Notice |
| S008 |
2005-09-30 |
Special (immediate Track) |
| S007 |
2005-06-27 |
30-day Notice |
| S006 |
2005-06-03 |
30-day Notice |
| S005 |
2005-04-07 |
30-day Notice |
| S004 |
2004-12-21 |
30-day Notice |
| S003 |
2004-12-15 |
30-day Notice |
| S002 |
2004-10-26 |
30-day Notice |
| S001 |
2004-05-24 |
30-day Notice |
NIH GUDID Devices