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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 herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples
De Novo Number DEN140004
510(K) Number K133448
Device Name QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
Requester
DIAGNOSTIC HYBRIDS, INC.
2005 e state st ste 100
athens,  OH  45701
Contact ronald h lollar
Regulation Number866.3309
Classification Product Code
PGI  
Date Received02/21/2014
Decision Date 05/13/2014
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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