Approval for the modification of the quality control testing specification for the 400 miu/ml calibrator in the device.
| Device | BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | BIO-RAD LABORATORIES |
| Date Received | 2012-02-22 |
| Decision Date | 2012-11-13 |
| PMA | P050048 |
| Supplement | S007 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIO-RAD LABORATORIES 6565 185th Ave, Ne redmond, WA 98052 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P050048 | | Original Filing |
| S009 |
2013-11-13 |
30-day Notice |
| S008 |
2012-10-19 |
30-day Notice |
| S007 |
2012-02-22 |
135 Review Track For 30-day Notice |
| S006 |
2010-06-18 |
135 Review Track For 30-day Notice |
| S005 |
2010-06-17 |
Normal 180 Day Track No User Fee |
| S004 |
2009-09-28 |
Normal 180 Day Track |
| S003 | | |
| S002 |
2008-09-30 |
Real-time Process |
| S001 |
2008-07-01 |
30-day Notice |
NIH GUDID Devices