BIO-RAD MONOLISA ANTI -HBS EIA
FDA premarket approval P050048/S006 · decided 2010-09-27
Approval details
- PMA number
- P050048
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2010-06-18
- Decision date
- 2010-09-27
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR A CHANGE IN SUPPLIER FOR THE HEPATITIS B ANTIGENS USED IN THE MANUFACTURE OF THE DEVICE.
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