COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
FDA premarket approval P050028/S005 · decided 2009-07-30
Approval details
- PMA number
- P050028
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2009-07-02
- Decision date
- 2009-07-30
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ELIMINATION OF FUNCTIONAL RELEASE TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.
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