510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213362Substantially Equivalent

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

BioFire Defense, LLC, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213362 is the FDA 510(k) clearance record for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel, a class II device, cleared for Biofire Defense, LLC on under FDA product code QVR (Multiplex Nucleic Acid Detection System For Biothreat Agents). FDA's definition for product code QVR reads: "A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens". FDA records list 10 510(k) clearances for Biofire Defense, LLC, from to . As of , FDA records show no recalls naming K213362.

Clearance record

Decision date
Received
(526 days to decision)
Product code
QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Regulation
21 CFR 866.4000
Device class
Class II
Review panel
Immunology
Applicant
Biofire Defense, LLC 79 W 4500 S, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVR

Trailing 12 months
1 clearance under product code QVR in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260