PMA P050042S016
- Device
- ARCHTECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S016
- Product code
- MZO
- Decision date
- 2012-04-13
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- ADD A PEROXIDE LEVEL QUALITY CONTROL TEST FOR ALL INCOMING VENDOR LOTS OF DETERGENT.
Current openFDA PMA Record#
- Device
- ARCHTECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S016
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2012-04-13
- Decision code
- OK30
- Date received
- 2012-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A PEROXIDE LEVEL QUALITY CONTROL TEST FOR ALL INCOMING VENDOR LOTS OF DETERGENT.