QMV

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

Product code

QMV

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.3966

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-12-05.

1 summaries are archived here for direct download.