• 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 orthopedic infection microbial multiplex nucleic acid detection system
De Novo Number DEN200066
Device Name BioFire Joint Infection (JI) Panel
BioFire Diagnostics, LLC
515 colorow drive
salt lake city,  UT  84108
Contact kevin bourzac
Regulation Number866.3988
Classification Product Code
Date Received10/27/2020
Decision Date 04/29/2022
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct