- Device
- ORAQUICK RAPID HCV ANTIBODY
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S003
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-10-20
- Decision code
- APPR
- Date received
- 2011-02-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR HOLD TIME EXTENSIONS FOR RAW MATERIAL, COMPONENTS AND IN-PROCESS MATERIAL FOR THE MANUFACTURING OF THE DEVICE.