Approval for expanding the intended use to include use with the evolisautomated microplate system. The device, as modified, will be marketed under the trade namemonolisa anti-hbc igm eia and is indicated for use in the qualitative detection of igmantibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassiumedta, 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. The monolisa anti-hbc igm is intended formanual use and with the bio-rad evolis automated microplate system in the detection ofigm antibodies to hepatitis b virus.
| Device | BIO-RAD MONOLISA ANTI-HBC IGM EIA |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Bio-Rad Laboratories, Inc. |
| Date Received | 2009-09-25 |
| Decision Date | 2010-08-02 |
| PMA | P060034 |
| Supplement | S004 |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Bio-Rad Laboratories, Inc. 6565 185th Ave., N.e. redmond, WA 98052 |
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