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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 Elecsys HIV combi PT
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Roche Diagnostics Operations, Inc.
9115 hague road po box 50457
Indianapolis , IN 46250 -0416
  
PMA NumberBP160050
Date Received06/02/2016
Decision Date06/21/2017
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S004 S005 S007 S009 S012 S013 S014 S017 
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