Approval for the bio-rad monolisa anti-hbc igm eia. The device is indicated for: the bio-rad monolisa anti-hbc igm eia is an enzyme immunoassay intended for use in the qualitative detection of igm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, sodium citrate, acd [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection.
| Device | BIO RAD MONOLISA ANTI-HBC IGM EIA |
| 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 | Bio-Rad Laboratories, Inc. |
| Date Received | 2006-11-22 |
| Decision Date | 2007-05-31 |
| Notice Date | 2007-06-28 |
| PMA | P060034 |
| Supplement | S |
| Product Code | LOM |
| Docket Number | 07M-0254 |
| 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 |
|---|
| P060034 | | Original Filing |
| S008 |
2014-02-26 |
30-day Notice |
| S007 |
2013-11-13 |
30-day Notice |
| S006 |
2012-10-19 |
30-day Notice |
| S005 |
2010-06-17 |
Normal 180 Day Track No User Fee |
| S004 |
2009-09-25 |
Normal 180 Day Track |
| S003 | | |
| S002 |
2008-09-30 |
Real-time Process |
| S001 |
2008-09-22 |
30-day Notice |
NIH GUDID Devices