FDA Product Code PEU: System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

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.

Leading manufacturers include Cepheid.