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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 Avioq HIV-1 Microelisa System
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Avioq, Inc.
9700 great seneca hwy.
Rockville , MD 20850 
  
PMA NumberBP090022
Date Received03/25/2009
Decision Date09/21/2009
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S004 S005 S010 S011 
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