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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 MedMira Rapid HIV 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
Date Received04/07/2000
Decision Date04/16/2003
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S007 S008 S010 S012 S015 S018 S019 S022 S024 
S026 S029 S030 S032 S033 S035 S038 S040 S041 
S043 S048 S050 S052 S056 
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