Bio-Rad Monolisa Anti-HBC IgM EIA
by Bio-Rad Laboratories, Inc. PMA
Active
PMA P060034
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP060034 | Date31 May 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
-
- Terminated Z-0065-2008
Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
Specification
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- PMA Number
- FDA Product Code
- SEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3173
- Advisory Committee
- Microbiology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Bio-Rad Monolisa Anti-HBC IgM EIA is an enzyme immunoassay (EIA) classified under qualitative and quantitative hepatitis B virus antibody assays. It is designed for the qualitative detection of IgM antibodies to hepatitis B core antigen (Anti-HBC IgM) in human serum or plasma collected with potassium EDTA, sodium citrate, acid citrate dextrose (ACD), lithium heparin, or sodium heparin. Results assist in the laboratory diagnosis of hepatitis B virus (HBV) disease associated with HBV infection when used alongside other HBV serological markers.
This assay is intended for use in microbiology laboratories and is supplied as a diagnostic reagent kit. It is approved under an FDA Premarket Approval (PMA) application (PMA Number: P060034) and falls under device class II (SEI product code). The device is not described as single-use or reusable, nor is MRI safety or sterility explicitly stated in the provided data. Storage and handling instructions are not included in the specifications, but compliance with standard laboratory protocols for immunoassays is implied.