System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
PEU · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3373
Classification
FDA Product Code
PEU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3373
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.