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 non-variola orthopoxvirus real-time pcr primer and probe set
De Novo Number DEN070001
Device Name NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
Requester
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 clifton rd., n.e.
atlanta,  GA  30333
Contact hye-joo kim
Regulation Number866.3315
Classification Product Code
PBK  
Date Received01/16/2007
Decision Date 09/21/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Post-NSE
-
-