Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit (product code OEH) is a microbiology in vitro diagnostic device used to aid in the diagnosis of pneumonic or typhoidal tularemia by performing qualitative PCR-based detection of target DNA sequences of Francisella tularensis in specimens from individuals presenting with signs and symptoms of infection. Tularemia is a potentially serious infectious disease caused by a Tier 1 select agent. This device is FDA Class 2 under regulation 866.3280 in the Microbiology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEH
- Device Class
- FDA class 2
- Regulation Number
- 866.3280
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.