BIO-RAD MONOLISA ANTI-HBC IGM EIA
FDA premarket approval P060034/S002 · decided 2009-02-20
Approval details
- PMA number
- P060034
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIO-RAD MONOLISA ANTI-HBC IGM EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 2008-09-30
- Decision date
- 2009-02-20
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- APPROVAL FOR AN AMENDMENT TO THE PACKAGE INSERT WITH THE ADDITION OF THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED FOR THE DEVICE.
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