OEH — Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit Class II
FDA product code OEH covers "Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit", a Class II medical device regulated under 21 CFR 866.3280. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OEH
- Device Class
- Class II
- Regulation Number
- 866.3280
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.