Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
| Device | ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS INC |
| Date Received | 2016-02-16 |
| Decision Date | 2016-03-16 |
| PMA | P140021 |
| Supplement | S006 |
| 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 | ROCHE DIAGNOSTICS OPERATIONS INC 9115 Hague Road p.o. Box 50416 indianapolis, IN 46250-0416 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P140021 | | Original Filing |
| S016 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S015 |
2018-10-09 |
30-day Notice |
| S014 |
2018-04-17 |
Real-time Process |
| S013 |
2018-03-01 |
Real-time Process |
| S012 |
2017-10-11 |
Real-time Process |
| S011 |
2017-08-03 |
30-day Notice |
| S010 |
2017-07-03 |
Normal 180 Day Track |
| S009 |
2017-05-24 |
30-day Notice |
| S008 |
2017-03-21 |
Normal 180 Day Track |
| S007 |
2016-09-30 |
Real-time Process |
| S006 |
2016-02-16 |
30-day Notice |
| S005 |
2016-01-29 |
Normal 180 Day Track |
| S004 |
2016-01-27 |
30-day Notice |
| S003 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S002 |
2015-12-17 |
Normal 180 Day Track |
| S001 |
2015-10-07 |
30-day Notice |
NIH GUDID Devices