Replace the current size exclusion chromatography system with a crossflow tangential flow purification system for the preparation of the biotin conjugate concentrate.
| 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 | 2017-08-28 |
| Decision Date | 2017-09-15 |
| PMA | P100001 |
| Supplement | S011 |
| 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 |
|---|
| 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