VERSANT HCV RNA 3.0 ASSAY (BDNA)
FDA premarket approval P020022/S010 · decided 2013-12-23
Approval details
- PMA number
- P020022
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- 2011-12-15
- Decision date
- 2013-12-23
- Days to decision
- 739 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS.
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