- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S007
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2012-12-17
- Decision code
- APPR
- Date received
- 2012-11-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A NEW QUALITY CONTROL TEST METHOD FOR EVALUATION OF A RAW MATERIAL USED IN THE MANUFACTURING OF THE DEVICE.