Replacement of key equipment used in performing the coated well test procedure and the acceptance criteria associated with its use. In addition, the coated well sampling plan, randomization methods for sampling, and test error correction methods have been improved to further ensure batch quality and reduction of production waste for the manufacture of the coated microwells.
| Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND 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 |
| Date Received | 2004-03-17 |
| Decision Date | 2004-04-02 |
| PMA | P030024 |
| Supplement | S001 |
| 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 100 Indigo Creek Dr. rochester, NY 14626-5101 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030024 | | Original Filing |
| S029 |
2019-05-21 |
30-day Notice |
| S028 |
2018-10-16 |
Normal 180 Day Track No User Fee |
| S027 |
2018-09-17 |
30-day Notice |
| S026 |
2018-02-21 |
Normal 180 Day Track No User Fee |
| S025 |
2018-01-09 |
Normal 180 Day Track No User Fee |
| S024 |
2017-08-07 |
30-day Notice |
| S023 |
2015-08-10 |
30-day Notice |
| S022 |
2015-06-25 |
30-day Notice |
| S021 |
2013-08-12 |
30-day Notice |
| S020 |
2012-10-17 |
30-day Notice |
| S019 |
2012-05-04 |
30-day Notice |
| S018 |
2012-01-30 |
30-day Notice |
| S017 |
2011-10-05 |
Real-time Process |
| S016 |
2011-05-16 |
135 Review Track For 30-day Notice |
| S015 |
2011-04-15 |
30-day Notice |
| S014 |
2010-12-06 |
135 Review Track For 30-day Notice |
| S013 |
2010-10-18 |
30-day Notice |
| S012 |
2009-12-01 |
Normal 180 Day Track No User Fee |
| S011 |
2009-03-06 |
30-day Notice |
| S010 |
2009-02-12 |
Normal 180 Day Track |
| S009 |
2008-11-13 |
Normal 180 Day Track No User Fee |
| S008 |
2008-01-23 |
30-day Notice |
| S007 |
2007-12-10 |
Real-time Process |
| S006 |
2007-05-11 |
30-day Notice |
| S005 |
2006-05-15 |
30-day Notice |
| S004 |
2005-11-14 |
30-day Notice |
| S003 |
2005-04-08 |
Special (immediate Track) |
| S002 |
2004-10-26 |
30-day Notice |
| S001 |
2004-03-17 |
30-day Notice |
NIH GUDID Devices