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OJONot classified

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

Unknown
FDA source (opens on fda.gov)

OJO is the FDA product code for Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OJO
Device name
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
FDA 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.
Device class
Not classified
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OJO.