Approval for an additional manufacturing site located at npa de méxico s. A. De c. V. Dba nypro, at sor juana ines de la cruz #20150, parque industrial chilpancingo, 22509 tijuana, baja california, mexico, limited to manufacturing of the ortho-clinical diagnostics vitros eci/eciq immunodiagnostic system.
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 | 2018-10-16 |
Decision Date | 2018-12-17 |
PMA | P030024 |
Supplement | S028 |
Product Code | LOM |
Advisory Committee | Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location 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