PMA P050042S010
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S010
- Product code
- MZO
- Decision date
- 2011-03-22
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S010
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-03-22
- Decision code
- APPR
- Date received
- 2011-02-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT IRELAND DIAGNOSTICS DIVISION IN SLIGO, IRELAND.