PMA P050042S025
- Device
- ARCHITECT ANTI-HCV LN 1L79
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S025
- Product code
- MZO
- Decision date
- 2013-08-30
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- ELIMINATION OF THE SPECIFICITY PANEL TESTING USED TO DETERMINE THE EFFECTIVENESS OF A PREVENTIVE ACTION.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV LN 1L79
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S025
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2013-08-30
- Decision code
- OK30
- Date received
- 2013-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF THE SPECIFICITY PANEL TESTING USED TO DETERMINE THE EFFECTIVENESS OF A PREVENTIVE ACTION.