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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunosorbent assay for the detection of lipoarabinomannan antigen of mycobacteria
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.
Product CodeOJO
Device Class Not Classified