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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 Reveal® G3 Rapid HIV-1 Antibody Test
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
MedMira Labs
155 chain lake drive, bayers lake
Halifax 
nova scotia CA B3S 1B3
PMA NumberBP000023
Supplement NumberS048
Date Received02/19/2014
Decision Date08/15/2014
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement TypeSpecial Supplement
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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