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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 Duo
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 NumberBP190403
Date Received09/27/2019
Decision Date04/10/2020
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S003 
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