5 results
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29ms
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Sources: EU EUDAMED, US FDA
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Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.
FDA Enforcement
Class III
·Terminated·Oxford Immunotec·September 23, 2020
T-Cell Xtend REF TTK.610 US
FDA Enforcement
Class II
·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022
AIM-V Medium REF AV.200/500
FDA Enforcement
Class II
·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022
T-SPOT.TB REF TB.300 US
FDA Enforcement
Class II
·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022