Approval for the bio-rad monolisa anti-hbc eia. The device is indicated for: the monolisa anti-hbc eia is an enzyme immunoassay intended for use in the qualitative detection of total antibodies (igg/igm) to hepatitis b core antigen (anti-hbc) in human serum and plasma (potassium edta, sodium citrate, acd (acid citrate dextrose), lithium heparin and sodium heparin). Assay results may be used with other hbv serological markets for the laboratory diagnosis of hbv disease associated with hbv infection.
| Device | BIO-RAD MONOLISA ANTI-HBC EIA |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Bio-Rad Laboratories, Inc. |
| Date Received | 2006-10-30 |
| Decision Date | 2007-04-27 |
| Notice Date | 2007-12-04 |
| PMA | P060031 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 07M-0467 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bio-Rad Laboratories, Inc. 6565 185th Ave., N.e. redmond, WA 98052 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060031 | | Original Filing |
| S007 |
2013-11-13 |
30-day Notice |
| S006 |
2012-10-19 |
30-day Notice |
| S005 |
2011-03-31 |
30-day Notice |
| S004 |
2010-06-17 |
Normal 180 Day Track No User Fee |
| S003 |
2009-09-28 |
Normal 180 Day Track |
| S002 |
2009-02-12 |
Special (immediate Track) |
| S001 |
2008-09-22 |
30-day Notice |
NIH GUDID Devices