QID

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Product code

QID

Device name

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

Device class

Class 2

21 CFR

21 CFR 866.4002

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

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

FDA classification definition

A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure.  Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.

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