PMA P050042S004
- Device
- ABBOTT ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S004
- Product code
- MZO
- Decision date
- 2009-01-28
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO THE LOT UNIFORMITY QUALITY CONTROL TEST METHOD.
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S004
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2009-01-28
- Decision code
- OK30
- Date received
- 2008-12-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE LOT UNIFORMITY QUALITY CONTROL TEST METHOD.