OEH

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Product code

OEH

Device name

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Device class

Class 2

21 CFR

21 CFR 866.3280

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).