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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 Uni-Gold Recombigen HIV-1
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
Date Received04/08/2003
Decision Date12/23/2003
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 S003 S017 S019 S020 S024 S029 
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