PMA P080027S009
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S009
- Product code
- MZO
- Decision date
- 2013-03-21
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- APPROVAL FOR ADDING MORE REPLICATES IN QC TESTING PROCEDURES.
Current openFDA PMA Record#
- Device
- ORAQUICK HCV RAPID ANTIBODY TEST
- Applicant
- OraSure Technologies, Inc.
- PMA number
- P080027
- Supplement
- S009
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2013-03-21
- Decision code
- APPR
- Date received
- 2013-02-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDING MORE REPLICATES IN QC TESTING PROCEDURES.