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

OEH · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3280

Classification

FDA Product Code: OEH
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3280
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown