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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 Orasure HIV-1 Oral Specimen Collection Device
Classification Namepoint of care hiv serology diagnostic and/or supplemental test
Generic Namepoint of care hiv serology diagnostic and/or supplemental test
Regulation Number866.3956
Applicant
OraSure Technologies, Inc
8505 sw creekside place
Beaverton , OR 97005 
  
PMA NumberBP910001
Date Received05/09/1991
Decision Date12/23/1994
Decision Approved
Product Code
QSU[ Registered Establishments with QSU ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S004 S006 S010 S016 S018 S025 S028 S034 
S035 S036 
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