- Device
- Alinity m HCV
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P190025
- Supplement
- S004
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2021-04-26
- Decision code
- APPR
- Date received
- 2021-01-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the design change to the access hole diameter of the Alinity m Universal Sample Rack Retention Bar.