MONOLISA ANTI-HBS EIA
FDA premarket approval P050048 · decided 2006-08-25
Approval details
- PMA number
- P050048
- Trade name
- MONOLISA ANTI-HBS EIA
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Bio-Rad Laboratories
- Date received
- 2005-12-05
- Decision date
- 2006-08-25
- Days to decision
- 263 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- 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 UNKN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.