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Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA product code QMV · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3966
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-10-20 – 2024-12-05

A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.

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