PMA P080027S025
- Device
- OraQuick HCV Rapid Antibody Test
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S025
- Product code
- MZO
- Decision date
- 2016-12-15
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Implementation of a second duplicate manufacturing area to produce materials used to manufacture a kit sub-component.
Current openFDA PMA Record#
- Device
- OraQuick HCV Rapid Antibody Test
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S025
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2016-12-15
- Decision code
- OK30
- Date received
- 2016-11-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a second duplicate manufacturing area to produce materials used to manufacture a kit sub-component.