- Device
- VERSANT HCV RNA 3.0 ASSAY (BDNA)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P020022
- Supplement
- S009
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2009-12-23
- Decision code
- OK30
- Date received
- 2009-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF AN IN-PROCESS TEST STEP FOR KIT COMPONENTS USED IN THE DEVICE.