PMA P010021S032
- Device
- VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S032
- Product code
- MZO
- Decision date
- 2019-06-19
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Establishment of a new Environmental Controlled Area Room at an existing facility.
Current openFDA PMA Record#
- Device
- VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- PMA number
- P010021
- Supplement
- S032
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2019-06-19
- Decision code
- OK30
- Date received
- 2019-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Establishment of a new Environmental Controlled Area Room at an existing facility.