Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
The Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test (ELISPOT) is an in vitro diagnostic test that detects effector T cells responding to stimulation by M. tuberculosis antigens ESAT-6 and CFP-10, indicated as an aid in diagnosing M. tuberculosis infection in conjunction with risk assessment, radiography, and other medical evaluations. Classified as FDA Class 3 requiring Premarket Approval (PMA), it is the highest risk class reflecting the critical role this test plays in tuberculosis diagnosis; it is reviewed by the Microbiology panel with no assigned regulation number. The product code is OJN. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OJN
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- MI
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.