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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 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
Supplement NumberS004
Date Received04/07/2016
Decision Date06/06/2016
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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