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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 Western Blot Kit
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
220 east first street
Bethlehem , PA 18015 -1360
  
PMA NumberBP950004
Date Received06/12/1995
Decision Date06/03/1996
Decision Approved
Product Code
QSU[ Registered Establishments with QSU ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S003 S005 S011 S013 
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