Approval for the advia centaur hcv. Hcv readypack reagents: the advia centaur hcv assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin g (igg) antibodies to hepatitis c virus (hcv) in human serum and plasma (edta, lithium or sodium heparinized) using the advia centaur system. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection. Hcv quality control materials: for in vitro diagnostic use in monitoring the performance of the hcv assay on the advia centaur systems. The performance of the hcv quality control material has not been established with any other anti-hcv assays.
| Device | ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2003-12-24 |
| Decision Date | 2004-12-22 |
| Notice Date | 2005-11-28 |
| PMA | P030056 |
| Supplement | S |
| Product Code | MZO |
| Docket Number | 05M-0478 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030056 | | Original Filing |
| S020 |
2021-04-01 |
30-day Notice |
| S019 |
2020-12-22 |
Real-time Process |
| S018 |
2020-07-31 |
30-day Notice |
| S017 |
2020-05-22 |
30-day Notice |
| S016 |
2020-03-09 |
30-day Notice |
| S015 |
2020-02-21 |
30-day Notice |
| S014 |
2019-02-01 |
30-day Notice |
| S013 |
2018-07-19 |
Real-time Process |
| S012 | | |
| S011 |
2017-09-29 |
Normal 180 Day Track |
| S010 |
2015-06-11 |
30-day Notice |
| S009 |
2015-05-01 |
Normal 180 Day Track |
| S008 |
2014-09-15 |
Normal 180 Day Track |
| S007 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S006 |
2009-05-18 |
Normal 180 Day Track |
| S005 |
2009-03-31 |
Normal 180 Day Track |
| S004 |
2009-03-09 |
Normal 180 Day Track No User Fee |
| S003 |
2009-02-04 |
30-day Notice |
| S002 |
2008-08-25 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices