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Sources: EU EUDAMED, US FDA
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Estrone RIA, REF: DSL8700
FDA Enforcement
Class II
·Ongoing·Immunotech A.S.·February 25, 2026
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
FDA Enforcement
Class II
·Ongoing·Immunotech A.S.·August 27, 2025
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