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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 ADVANCE Rapid HIV-1/2 Antibody Test
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
150 webster street
Bethlehem , PA 18015 -1389
  
PMA NumberBP010047
Date Received11/13/2001
Decision Date11/07/2002
Decision Approved
Product Code
QSU[ Registered Establishments with QSU ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S006 S007 S008 S010 S011 S012 S015 S016 S017 
S019 S022 S023 S025 S029 S030 S031 S032 S035 
S036 S040 S041 S042 S043 S045 S046 S048 S050 
S051 S052 S054 S055 S056 S058 S059 S060 S061 
S062 S065 S066 S067 S068 S071 S073 S074 S078 
S079 S082 S092 S093 S097 S100 S101 S103 
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