QMV

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3966

Medical specialty

Microbiology

FDA definition

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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