- Device
- VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S031
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2018-12-17
- Decision code
- APPR
- Date received
- 2018-10-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional manufacturing site located at NPA de México S.A. de C.V. dba Nypro, at Sor Juana Ines de la Cruz #20150, Parque Industrial Chilpancingo, 22509 Tijuana, Baja California, Mexico, limited to manufacturing of the Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System