BIO-RAD MONOLISA ANTI-HBS EIA
FDA premarket approval P050048/S004 · decided 2011-04-25
Approval details
- PMA number
- P050048
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIO-RAD MONOLISA ANTI-HBS EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories
- Date received
- 2009-09-28
- Decision date
- 2011-04-25
- Days to decision
- 574 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR USE OF THE MONOLISA ANTI-HBS EIA ON THE EVOLIS AUTOMATED MICROPLATE SYSTEM, ADDING LITHIUM HEPARIN AND SODIUM HEPARIN TO THE LIST OF ACCEPTABLE PLASMA SPECIMEN TYPES, A CHANGE IN THE DYE COLOR IN THE CUTOFF CALIBRATOR, REVISION TO THE SPECIMEN STORAGE REQUIREMENTS, AND MODIFICATION OF THE STORAGE INSTRUCTIONS FOR THE WORKING CONJUGATE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MONOLISA ANTI-HBS EIA AND IS INDICATED FOR THE DETECTION OF ANTIBODY TO HEPATITIS B SU
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