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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 microbial colonization directly from clinical specimens.
De Novo Number DEN230092
Device Name Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
Requester
diasorin molecular, llc
11331 valley view st.
cypress,  CA  90630
Contact michele chwedoruk
Regulation Number866.3967
Classification Product Code
SBT  
Date Received12/28/2023
Decision Date 07/15/2024
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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