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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORAQUICK HCV RAPID ANTIBODY TEST
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
Generic Nameassay,enzyme linked immunosorbent,hepatitis c virus
Applicant
ORASURE TECHNOLOGIES INC.
220 east first street
bethlehem, PA 18015
PMA NumberP080027
Supplement NumberS011
Date Received04/29/2013
Decision Date05/28/2013
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OF THE ADDITION OF A VISUAL INSPECTION STEP IN THE ORAQUICK® HCV RAPID ANTIBODY TEST ASSAY CARD MANUFACTURING PROCESS.
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