- Device
- VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S033
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2020-08-07
- Decision code
- OK30
- Date received
- 2020-07-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Amendment of the assay specific release for sale limits used in the release testing of Immunodiagnostic Products, VITROS Anti-HCV reagent pack and calibrators.