- Device
- ELECSYS ANTI-HCV II IMMUNOASSAY
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S003
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2016-08-08
- Decision code
- APPR
- Date received
- 2016-01-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the final kit packaging configuration, modifications to an existing packaging line, and addition of two new packaging lines.