PMA P050042S043
- Device
- ARCHITECT Anti-HCV and Alinity i Anti-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S043
- Product code
- MZO
- Decision date
- 2020-04-29
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Change in supplier's manufacturing site of a critical assay component.
Current openFDA PMA Record#
- Device
- ARCHITECT Anti-HCV and Alinity i Anti-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S043
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2020-04-29
- Decision code
- OK30
- Date received
- 2020-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier's manufacturing site of a critical assay component.