PMA P080027S005
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S005
- Product code
- MZO
- Decision date
- 2011-07-27
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR THE OPTION TO AUTOMATE THE MANUFACTURING PROCESS FOR ASSEMBLY OF THE ORAQUICK® HCV RAPID ANTIBODY TEST.
Current openFDA PMA Record#
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S005
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-07-27
- Decision code
- APPR
- Date received
- 2011-03-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Approval order statement
- APPROVAL FOR THE OPTION TO AUTOMATE THE MANUFACTURING PROCESS FOR ASSEMBLY OF THE ORAQUICK® HCV RAPID ANTIBODY TEST.