MWA

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Product code

MWA

Device name

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Device class

Class 2

21 CFR

21 CFR 866.3372

Medical specialty

Microbiology

Marketing pathway

510(K)

FDA classification definition

intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

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