BIO-RAD MONOLISA ANTI-HBS EIA
FDA premarket approval P050048/S002 · decided 2010-03-12
Approval details
- PMA number
- P050048
- Supplement
- S002
- Supplement type
- Real-Time Process
- 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
- 2008-09-30
- Decision date
- 2010-03-12
- Days to decision
- 528 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR THE MONOLISA ANTI-HBS EIA PACKAGE INSERT IN ORDER TO ADD THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, WITH UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED.
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