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 over-the-counter molecular test to detect sars-cov-2 from clinical specimens
De Novo Number DEN220028
Device Name Cue COVID-19 Molecular Test
Requester
cue health inc.
4980 carroll canyon road suite 100
san diego,  CA  92121
Contact roderick castillo
Regulation Number866.3984
Classification Product Code
QWB  
Date Received05/02/2022
Decision Date 06/06/2023
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-