510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131936Substantially Equivalent

Jbaids Tularemia Detection Kit

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

K131936 is the FDA 510(k) clearance record for JBAIDS TULAREMIA DETECTION KIT, a class II device, cleared for Biofire Diagnostics, Inc. on under FDA product code OEH (Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit). FDA's definition for product code OEH reads: "To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis". FDA records list 35 510(k) clearances for Biofire Diagnostics, Inc., from to . As of , FDA records show no recalls naming K131936.

Clearance record

Decision date
Received
(34 days to decision)
Product code
OEH Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Regulation
21 CFR 866.3280
Device class
Class II
Review panel
Microbiology
Applicant
Biofire Diagnostics, Inc. 390 Wakara Way, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEH

Trailing 12 months

FDA records hold no clearances under product code OEH in the trailing twelve months.

FDA records show no clearances under product code OEH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OEH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260