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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 nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
De Novo Number DEN200015
Device Name cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Requester
roche molecular systems, inc.
4300 hacienda drive
pleasanton,  CA  94588 -2722
Contact rita hoady
Regulation Number866.3183
Classification Product Code
QLX  
Date Received03/02/2020
Decision Date 07/30/2020
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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