Approval for the addition of two washes of the ancillary probe on the advia centaur and advia centaur xp instruments when the advia centaur hbsag assay is run immediately following the advia centaur syphilis assay.
| Device | ADVIA CENTAUR HBSAG (HBS) ASSAY |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2014-07-10 |
| Decision Date | 2014-10-28 |
| PMA | P030049 |
| Supplement | S011 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030049 | | Original Filing |
| S016 |
2020-12-22 |
Real-time Process |
| S015 |
2020-07-31 |
30-day Notice |
| S014 |
2020-02-21 |
30-day Notice |
| S013 |
2019-09-27 |
30-day Notice |
| S012 |
2015-06-11 |
30-day Notice |
| S011 |
2014-07-10 |
Real-time Process |
| S010 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S009 | | |
| S008 |
2010-04-06 |
30-day Notice |
| S007 |
2009-05-18 |
Normal 180 Day Track |
| S006 |
2009-05-12 |
30-day Notice |
| 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 |
2008-07-30 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices