- Device
- Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S034
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2019-06-18
- Decision code
- APPR
- Date received
- 2018-04-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for migration of the ARCHITECT Anti-HCV Reagent kit, ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Controls onto the Alinity i Analyzer. The manufacture of the Alinity i analyzer would be done at a new contract manufacturer, Sanmina, Singapore.