OJN — Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test Class III
FDA product code OJN covers "Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OJN
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
Definition
For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.