Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
- US Product Code (FDA)
- OJNView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test 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.
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