Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
Basic Information
- Device Name
- Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
- Trade Name
- MONOLISA ANTI-HBS EIA
- PMA Number
- P050048
- Device Class
- FDA Class 3
- Product Code
- LOM
- Generic Name
- Test, hepatitis b (b core, be antigen, be antibody, b core igm)
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 25, 2006
- Date Received
- December 5, 2005
- Expedited Review
- N
- Docket Number
- 07M-0151
Advisory Committee Statement
APPROVAL FOR THE MONOLISA ANTI-HBS EIA AND THE MONOLISA ANTI-HBS CALIBRATOR KIT. THE DEVICES ARE INDICATED FOR: THE MONOLISA ANTI-HBS EIA IS A QUALITATIVE AND QUANTITATIVE ENZYME IMMUNOASSAY FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM AND EDTA OR CITRATED PLASMA. THE ASSAY RESULTS MAY BE USED AS AN AID IN THE DETERMINATION OF SUSCEPTIBILITY TO HEPATITIS B VIRUS (HBV) INFECTION IN INDIVIDUALS PRIOR TO OR FOLLOWING HBV VACCINATION OR WHERE VACCINATION STATUS IS UNKNOWN. ASSAY RESULTS MAY BE USED WITH OTHER HBV SEROLOGICAL MARKERS FOR THE LABORATORY DIAGNOSIS OF HBV DISEASE ASSOCIATED WITH HBV INFECTION. A REACTIVE ASSAY RESULT WILL ALLOW A DIFFERENTIAL DIAGNOSIS IN INDIVIDUALS DISPLAYING SIGNS AND SYMPTOMS OF HEPATITIS IN WHOM ETIOLOGY IS UNKNOWN. THE MONOLISA ANTI-HBS CALIBRATOR KIT IS INTENDED FOR QUANTITATIVE DETERMINATION OF ANTI-HBS IN HUMAN SERUM AND EDTA OR CITRATED PLASMA. THE MONOLISA ANTI-HBS CALIBRATOR KIT IS TO BE USED ONLY WITH THE MONOLISA ANTI-HBS EIA.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | FDA class 3 | Unknown |