PEU

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3373

Medical specialty

Microbiology

FDA definition

The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

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