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 3600 immunodiagnostic system.
Device | VITROS Immunodiagnostic Products Anti-HBe 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 | 2018-01-09 |
Decision Date | 2018-07-02 |
PMA | P100001 |
Supplement | S012 |
Product Code | LOM |
Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
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 |
P100001 | | Original Filing |
S017 |
2022-09-30 |
Real-time Process |
S016 |
2019-05-21 |
30-day Notice |
S015 |
2018-10-16 |
Normal 180 Day Track No User Fee |
S014 |
2018-02-21 |
Normal 180 Day Track No User Fee |
S013 |
2018-01-25 |
30-day Notice |
S012 |
2018-01-09 |
Normal 180 Day Track No User Fee |
S011 |
2017-08-28 |
30-day Notice |
S010 |
2016-11-17 |
Normal 180 Day Track |
S009 |
2016-09-12 |
30-day Notice |
S008 |
2015-08-10 |
30-day Notice |
S007 |
2015-06-25 |
30-day Notice |
S006 |
2013-09-20 |
30-day Notice |
S005 |
2012-11-29 |
30-day Notice |
S004 |
2012-10-26 |
30-day Notice |
S003 |
2012-10-17 |
30-day Notice |
S002 |
2012-09-19 |
30-day Notice |
S001 |
2012-03-22 |
30-day Notice |
NIH GUDID Devices