|Trade Name||ORAQUICK HCV RAPID ANTIBODY TEST|
|Classification Name||assay,enzyme linked immunosorbent,hepatitis c virus|
|Applicant||ORASURE TECHNOLOGIES INC.|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|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.