- Device
- ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S045
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2021-04-22
- Decision code
- APPR
- Date received
- 2021-02-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to modify the ARCHITECT i1000SR probe wash with an alternate wash delivery system (AWDS), and to modify the ARCHITECT i2000SR and Alinity i with Induction Heating (IH).