BIO-RAD MONOLOSA ANTI-HBC EIA
FDA premarket approval P060031/S001 · decided 2008-10-09
Approval details
- PMA number
- P060031
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIO-RAD MONOLOSA ANTI-HBC EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2008-09-22
- Decision date
- 2008-10-09
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- ADDING A NEW FILLING MACHINE FOR USE IN THE MANUFACTURING OF THE POSITIVE AND NEGATIVE CONTROL VIALS AND THE CALIBRATOR VIAL IN THE KIT.
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