FDA product code OJO

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

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
OJO
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US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.