Device Dossier
Mycobacteria IVDs
Device Dossier for Mycobacteria IVDs (CT791 - Mycobacteria IVDs, Class 3, sponsor Revvity). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT791 - Mycobacteria IVDs
Intended purpose
The T-SPOT.TB test is an in vitro diagnostic test for the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens and is intended for use as an aid in the diagnosis of tuberculosis (TB) infection. The T-SPOT.TB test is a simplified enzyme-linked immunospot (ELISPOT) method which enumerates individual TB-specific activated effector T cells.