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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 Alere DetermineTM HIV-1/2 Ag/Ab Combo
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
Abbott Diagnostics Scarborough, Inc.
10 southgate road
Scarborough , ME 04074 
  
PMA NumberBP120037
Supplement NumberS018
Date Received01/30/2019
Decision Date02/26/2019
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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