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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device OraQuick® In-Home HIV Test
Classification Namehiv self-tests
Generic Namehiv self-tests
Applicant
OraSure Technologies, Inc
Bethlehem  , PA  18015  -1360
PMA NumberBP120001
Date Received01/09/2012
Decision Date07/03/2012
Decision Approved
Product Code
QSS[ Registered Establishments with QSS ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S016 S021 S023 S072 S084 S087 S137 S224 S265 
S266 S276 S278 S297 S300 S305 S335 S336 S374 
S408 S464 S542 S549 S596 S620 S621 S645 S665 
S697 S703 S714 S718 S719 S720 S721 S753 S780 
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