PMA P050042S017
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S017
- Product code
- MZO
- Decision date
- 2012-07-31
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO USE NEW CONTAINERS FOR MANUFACTURING OF MICROPARTICLE BASEDCOMPONENTS AND IMPLEMENTING A NEW TEST TO VERIFY THE EFFECTIVENESS OF THE PREVENTIVE ACTION.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S017
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2012-07-31
- Decision code
- OK30
- Date received
- 2012-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO USE NEW CONTAINERS FOR MANUFACTURING OF MICROPARTICLE BASEDCOMPONENTS AND IMPLEMENTING A NEW TEST TO VERIFY THE EFFECTIVENESS OF THE PREVENTIVE ACTION.