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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.
 
Device OraQuick? In-Home HIV Test
Classification Namehiv self-tests
Generic Namehiv self-tests
Applicant
OraSure Technologies, Inc
220 east first street
Bethlehem , PA 18015 -1360
  
PMA NumberBP120001
Supplement NumberS266
Date Received09/28/2015
Decision Date10/27/2015
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
QSS[ Registered Establishments with QSS ]
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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