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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 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
Supplement NumberS014
Date Received01/13/2021
Decision Date01/28/2021
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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