OJN

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Product code: OJN
Device name: Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OJN

Classification and pathway per current FDA publications. Data from openFDA (CC0).