PMA P970027S008
- Device
- ABBOTT AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S008
- Product code
- MZO
- Decision date
- 2010-05-13
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO THE EFFICACY TESTING PERFORMED ON NEW INCOMING LOTS OF CONJUGATE CONCENTRATE FOR THE DEVICE.
Current openFDA PMA Record
- Device
- ABBOTT AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S008
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2010-05-13
- Decision code
- OK30
- Date received
- 2010-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE EFFICACY TESTING PERFORMED ON NEW INCOMING LOTS OF CONJUGATE CONCENTRATE FOR THE DEVICE.