PMA P080027S024
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S024
- Product code
- MZO
- Decision date
- 2016-11-18
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Alternate supplier of the OraQuick housing, top and base, used in the manufacture of the device.
Current openFDA PMA Record#
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S024
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2016-11-18
- Decision code
- OK30
- Date received
- 2016-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of the OraQuick housing, top and base, used in the manufacture of the device.