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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameORAQUICK HCV RAPID ANTIBODY TEST
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantORASURE TECHNOLOGIES INC.
PMA NumberP080027
Supplement NumberS017
Date Received06/06/2014
Decision Date09/02/2014
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product 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.
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