PMA P010021S028
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S028
- Product code
- MZO
- Decision date
- 2016-11-30
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Introduction of an additional supplier for negative plasma and in-house processing steps for plasma provided by the new supplier.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S028
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2016-11-30
- Decision code
- OK30
- Date received
- 2016-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an additional supplier for negative plasma and in-house processing steps for plasma provided by the new supplier.