Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
-
-