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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name device to detect and measure procalcitonin (pct) in human clinical specimens
De Novo Number DEN150009
Device Name B.R.A.H.M.S PCT sensitive KRYPTOR
Requester
b.r.a.h.m.s gmbh
neuendorfstr. 25
hennigsdorf,  DE 16761
Contact bernhard ciommer
Regulation Number866.3215
Classification Product Code
PMT  
Date Received03/04/2015
Decision Date 02/20/2016
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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