This supplement is for labeling changes as a result of biotin interference testing.
| Device | ADVIA Centaur HBsAg ReadyPack Reagents/ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents, ADVIA Centaur HBsAg Quality |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2020-12-22 |
| Decision Date | 2021-03-11 |
| PMA | P030049 |
| Supplement | S016 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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