PMA P050042S038
- Device
- ARCHITECT Anti-HCV Reagent Kit
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S038
- Product code
- MZO
- Decision date
- 2019-01-24
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Change of a supplier test method used to qualify critical raw materials.
Current openFDA PMA Record#
- Device
- ARCHITECT Anti-HCV Reagent Kit
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S038
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2019-01-24
- Decision code
- OK30
- Date received
- 2018-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of a supplier test method used to qualify critical raw materials.