COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM
FDA premarket approval P060030/S015 · decided 2011-02-24
Approval details
- PMA number
- P060030
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-02-08
- Decision date
- 2011-02-24
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS TAQMAN HCV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY.
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510(k) clearances by this applicant
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|---|---|---|
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