OJO

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

Product code: OJO
Device name: Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Contact ODE

FDA classification definition

Enzyme linked immunosorbent assay (elisa) system intended for in vitro diagnostic use to qualitatively detect the presence of lipoarabinomannan (lam) antigen of mycobacteria in human urine as an aid in the diagnosis of current mycobacterial infection in hiv positive patients with systems of tuberculosis.

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

Official FDA classification page: OJO

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