FDA product code OEH

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

Microbiology·Class 2·21 CFR 866.3280
US regulatory classifications
US Product Code (FDA)
OEH
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3280
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.

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About this record

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.