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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 RAPID HCV ANTIBODY
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantORASURE TECHNOLOGIES INC.
PMA NumberP080027
Supplement NumberS003
Date Received02/23/2011
Decision Date10/20/2011
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for hold time extensions for raw material, components and in-process material for the manufacturing of the device.
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