PMA P050042S022
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S022
- Product code
- MZO
- Decision date
- 2013-03-13
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.
Current openFDA PMA Record#
- Device
- ARCHITECT ANTI-HCV
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S022
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2013-03-13
- Decision code
- OK30
- Date received
- 2013-02-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE AN IN-PROCESS QUALITY CONTROL TEST METHOD TO CONTINUE PRODUCTION OF THE ANTI-HBS NEGATIVE HUMAN PLASMAS USED IN THE MANUFACTURE OF THE ARCHITECT ASSAYS.