PMA P050042S036
- Device
- Architect Anti-HCV Regent Kit (100, 500 Test)
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S036
- Product code
- MZO
- Decision date
- 2018-11-07
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Implement mixing and scale-up processes for bulk materials.
Current openFDA PMA Record#
- Device
- Architect Anti-HCV Regent Kit (100, 500 Test)
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050042
- Supplement
- S036
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2018-11-07
- Decision code
- OK30
- Date received
- 2018-10-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement mixing and scale-up processes for bulk materials.