Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
OJO · Not classified · Unknown
Classification
FDA Product Code
OJO
Device class
Not classified
Regulation
—
Review panel
MI
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.