Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
Medical specialty
Microbiology
Device class
2
Regulation number
866.3280
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.