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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 non-factor replacement product test system
De Novo Number DEN240035
Device Name ConcizuTrace™ ELISA
Requester
randox laboratories ltd
55 diamond road
crumlin,  GB bt29 4qy
Contact karena shaw
Regulation Number864.7298
Classification Product Code
SES  
Date Received07/01/2024
Decision Date 05/22/2025
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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