- Device
- VERSANT HCV RNA 3.0 ASSAY (BDNA)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P020022
- Supplement
- S010
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2013-12-23
- Decision code
- APPR
- Date received
- 2011-12-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS.