PMA P050042S040
- Device
- Alinity i Anti-HCV Reagent Kit
- Applicant
- Abbott Laboratories, Inc.
- Product code
- MZO
- Decision date
- 2020-06-05
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Approval for the release of the updated Alinity software.
Current openFDA PMA Record#
- Device
- Alinity i Anti-HCV Reagent Kit
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S040
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2020-06-05
- Decision code
- APPR
- Date received
- 2020-03-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the release of the updated Alinity software.