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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 BioPlex? 2200 HIV Ag-Ab
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Bio-Rad Laboratories
6565 185th ave ne clinical diagnostics group
Redmond , WA 98052 -5039
  
PMA NumberBP140111
Date Received03/31/2014
Decision Date07/23/2015
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S003 S004 S005 S010 
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