JBAIDS ANTHRAX DETECTION KIT— 510(k) K131930

Clearance details

Applicant

Biofire Diagnostics, Inc.

Product code

Code NHT

Device class

Class 2

Regulation

21 CFR 866.3045

Advisory panel

Microbiology

Date received

2013-06-27

Decision date

2013-08-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

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• K131729 — JBAIDS PLAGUE DETECTION KIT2013-07-31
• K131936 — JBAIDS TULAREMIA DETECTION KIT2013-07-31
• K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL2013-06-21
• K123620 — FILMARRAY RESPIRATORY PANEL (RP)2013-02-11

• Z-2644-2014 — JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument provides an integrated environment for performing the required functions to control JBAIDS instruments and to perform PCR tests and analysis.Class III·Terminated·Biofire Defense·20140813

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131930.