PMA P080027S017
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S017
- Product code
- MZO
- Decision date
- 2014-09-02
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR CHANGES TO THE EXPIRATION DATING FOR THE ORAQUICK® HCV VISUAL REFERENCE PANEL TO A FIVE MONTH EXPIRATION DATE FOR POUCHED AND UN-POUCHED DEVICES THAT ARE PROTECTED FROM LIGHT AND 15 DAYS FOR DEVICES THAT ARE NOT PROTECTED FROM LIGHT.
Current openFDA PMA Record#
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S017
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2014-09-02
- Decision code
- APPR
- Date received
- 2014-06-06
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR CHANGES TO THE EXPIRATION DATING FOR THE ORAQUICK® HCV VISUAL REFERENCE PANEL TO A FIVE MONTH EXPIRATION DATE FOR POUCHED AND UN-POUCHED DEVICES THAT ARE PROTECTED FROM LIGHT AND 15 DAYS FOR DEVICES THAT ARE NOT PROTECTED FROM LIGHT.