PMA P970027S015
- Device
- AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S015
- Product code
- MZO
- Decision date
- 2011-10-07
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.
Current openFDA PMA Record
- Device
- AXSYM ANTI-HCV
- Applicant
- Abbott Laboratories
- PMA number
- P970027
- Supplement
- S015
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-10-07
- Decision code
- APPR
- Date received
- 2011-09-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE.