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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 assayed external control material for microbiology nucleic acid amplification (nat) assays
De Novo Number DEN150058
Device Name Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
Requester
bio-rad laboratories
9500 jeronimo road
irvine,  CA  92614
Contact elizabeth platt
Regulation Number866.3920
Classification Product Code
PMN  
Date Received12/16/2015
Decision Date 03/28/2016
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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