• 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 variola virus nucleic acid-based detection assay
De Novo Number DEN160016
Device Name Variola virus Real-Time PCR Assay
Requester
centers for disease control and prevention (cdc)
1600 clifton road ne, ms-c18
atlanta,  GA  30329
Contact yon yu
Regulation Number866.3316
Classification Product Code
PRA  
Date Received04/14/2016
Decision Date 02/06/2017
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Direct
-
-