Amendment of the assay specific release for sale limits used in the release testing of immunodiagnostic products, vitros anti-hcv reagent pack and calibrators.
Device | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator |
Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
Applicant | Ortho-Clinical Diagnostics, Inc. |
Date Received | 2020-07-20 |
Decision Date | 2020-08-07 |
PMA | P010021 |
Supplement | S033 |
Product Code | MZO |
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 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P010021 | | Original Filing |
S033 |
2020-07-20 |
30-day Notice |
S032 |
2019-05-21 |
30-day Notice |
S031 |
2018-10-16 |
Normal 180 Day Track No User Fee |
S030 |
2018-02-21 |
Normal 180 Day Track No User Fee |
S029 |
2018-01-09 |
Normal 180 Day Track No User Fee |
S028 |
2016-10-21 |
30-day Notice |
S027 |
2015-08-10 |
30-day Notice |
S026 |
2015-06-25 |
30-day Notice |
S025 |
2014-11-17 |
135 Review Track For 30-day Notice |
S024 |
2013-02-08 |
30-day Notice |
S023 |
2012-10-17 |
30-day Notice |
S022 |
2012-01-30 |
30-day Notice |
S021 |
2011-10-05 |
Real-time Process |
S020 |
2011-06-14 |
135 Review Track For 30-day Notice |
S019 |
2011-03-24 |
135 Review Track For 30-day Notice |
S018 |
2010-04-26 |
30-day Notice |
S017 |
2009-12-01 |
Normal 180 Day Track No User Fee |
S016 |
2009-03-30 |
Normal 180 Day Track |
S015 |
2009-03-06 |
30-day Notice |
S014 |
2008-11-13 |
Normal 180 Day Track No User Fee |
S013 |
2008-03-20 |
Real-time Process |
S012 |
2008-01-23 |
30-day Notice |
S011 |
2007-06-05 |
30-day Notice |
S010 |
2007-03-28 |
30-day Notice |
S009 | | |
S008 |
2005-11-16 |
30-day Notice |
S007 |
2005-09-16 |
Normal 180 Day Track |
S006 |
2005-06-27 |
135 Review Track For 30-day Notice |
S005 |
2005-02-02 |
Special (immediate Track) |
S004 |
2004-10-26 |
30-day Notice |
S003 |
2004-07-16 |
30-day Notice |
S002 |
2004-07-07 |
30-day Notice |
S001 |
2003-04-11 |
30-day Notice |
NIH GUDID Devices