PMA P050042
- Device
- ARCHITECT Anti-HCV / Alinity i Anti-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S047
- Product code
- MZO
- Decision date
- 2021-12-15
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Change a raw material supplier.
Current openFDA PMA Record#
- Device
- ARCHITECT Anti-HCV / Alinity i Anti-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S047
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2021-12-15
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change a raw material supplier.