Product code MWA

Device name

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Medical specialty

Microbiology

Device class

2

Regulation number

866.3372

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset