PMA P050042S008
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S008
- Product code
- MZO
- Decision date
- 2011-01-14
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S008
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-01-14
- Decision code
- APPR
- Date received
- 2010-12-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL FOR THE ARCHITECT PRE-TRIGGER SOLUTION.