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U.S. Department of Health and Human Services

Product Classification
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Device mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
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.
Physical State In vitro diagnostic kit
Technical Method Enzyme-linked immunospot assay
Target Area Peripheral Blood
Review Panel Microbiology
Product CodeOJN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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