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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 NumberS010
Date Received01/29/2019
Decision Date02/06/2019
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Supplement Type 30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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