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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 Uni-Gold¿ Recombigen® HIV
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Trinity Biotech
ida business park southern cross road
bray, co. wicklow IE 
PMA NumberBP030025
Supplement NumberS019
Date Received09/18/2012
Decision Date02/04/2013
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypePanel Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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