FDA product code OJO: Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
OJO is the FDA product code for enzyme linked immunosorbent assay for the detection of lipoarabinomannan antigen of mycobacteria. It is a Not classified device, reviewed by the Microbiology panel. Devices under OJO reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria |
| Device class | Not classified |
| Review panel | MI — Microbiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for OJO devices
openFDA lists no recalls for product code OJO.
Frequently asked questions
What is FDA product code OJO?
OJO is the FDA product code for enzyme linked immunosorbent assay for the detection of lipoarabinomannan antigen of mycobacteria. It is a Not classified device, reviewed by the Microbiology panel.
What device class is OJO?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OJO
- Run a recall and safety report across every OJO manufacturer
- Watch product code OJO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.