PMA P970027S013
- Device
- AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S013
- Product code
- MZO
- Decision date
- 2011-04-15
- 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
- AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S013
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-04-15
- Decision code
- APPR
- Date received
- 2011-01-31
- 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.