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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 DPP HIV 1/2 Assay
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
Chembio Diagnostic Systems, Inc.
3661 horseblock road
Medford , NY 11763 
  
PMA NumberBP120032
Supplement NumberS006
Date Received03/30/2015
Decision Date04/27/2015
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
QSU[ Registered Establishments with QSU ]
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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