BioFire Joint Infection (JI) Panel

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

BioFire Diagnostics, LLC

The following data is part of a De Novo classification by Biofire Diagnostics, Llc with the FDA for Biofire Joint Infection (ji) Panel.

Pre-market Notification Details

DeNovo IDDEN200066
Device Name:BioFire Joint Infection (JI) Panel
ClassificationOrthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Applicant BioFire Diagnostics, LLC 515 Colorow Drive Salt Lake City,  UT  84108
ContactKevin Bourzac
Product CodeQSN  
CFR Regulation Number866.3988 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypeDirect
Date Received2020-10-27
Decision Date2022-04-29
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815381020192 DEN200066 000

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