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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeOJN
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 3 2 0 4 1

Recalls
Manufacturer Recall Class Date Posted
1 OXFORD IMMUNOTEC LTD II Aug-26-2022
2 Oxford Immunotec III Sep-16-2020
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