BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)
FDA premarket approval P020022/S005 · decided 2007-08-01
Approval details
- PMA number
- P020022
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2006-12-20
- Decision date
- 2007-08-01
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR TRANSFER OF THE MANUFACTURE OF THE WASH REAGENTS (WASH A AND WASH B) TO A CONTRACT MANUFACTURER. THE NUMBER OF BOTTLES PER LOT WILL BE INCREASED FOR BOTH WASH A AND WASH B.
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