510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131729Substantially Equivalent

Jbaids Plague 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)

K131729 is the FDA 510(k) clearance record for JBAIDS PLAGUE DETECTION KIT, cleared for Biofire Diagnostics, Inc. on under FDA product code OIH (Yersinia Spp. Reagents). FDA's definition for product code OIH reads: "Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical...". FDA records list 35 510(k) clearances for Biofire Diagnostics, Inc., from to . As of , FDA records show no recalls naming K131729.

Clearance record

Decision date
Received
(49 days to decision)
Product code
OIH Yersinia Spp. Reagents
Device class
Unclassified
Review panel
Unknown
Applicant
Biofire Diagnostics, Inc. 390 Wakara Way, Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIH

Trailing 12 months

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

FDA records show no clearances under product code OIH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIH, 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