22 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OXFORD IMMUNOTEC LTD
FDA registration
OXFORD IMMUNOTEC LTD·2 products·🇬🇧 United Kingdom
T.Cell Xtend®
FDA UDI
Oxford Immunotec, Inc.·15051716000053·Approval for the use of t-cell xtend reagent wi...
T-SPOT®.TB96
FDA UDI
Oxford Immunotec, Inc.·15051716000008·For the detection of effector t cells that resp...
Leucosep Tubes
FDA UDI
Oxford Immunotec, Inc.·05051716000544·Leucosep® tubes are intended for use in the col...
T-SPOT®.TB50
FDA UDI
Oxford Immunotec, Inc.·15051716000046·For the detection of effector t cells that resp...
T-Cell Select®
FDA UDI
Oxford Immunotec, Inc.·05051716000131·The T-SPOT.TB test has been evaluated for the p...
T.Cell Xtend®
FDA UDI
Oxford Immunotec, Inc.·15051716000022·Approval for the use of t-cell xtend reagent wi...
T-Cell Select®
FDA UDI
Oxford Immunotec, Inc.·05051716000186·The T-SPOT.TB test has been evaluated for the p...
AIM-V Medium
FDA UDI
Oxford Immunotec, Inc.·05051716000162·AIM-V® serum free cell culture medium is intend...
T-SPOT®.TB8
FDA UDI
Oxford Immunotec, Inc.·15051716000305·For the detection of effector t cells that resp...
Leucosep Tubes
FDA UDI
Oxford Immunotec, Inc.·05051716000087·Leucosep® tubes are intended for use in the col...
AIM-V Medium
FDA UDI
Oxford Immunotec, Inc.·05051716000155·AIM-V® serum free cell culture medium is intend...
T-Cell Xtend REF TTK.610 US
FDA Recall
Open, Classified
·OXFORD IMMUNOTEC LTD
143 Park Road
Abingdon United Kingdom·Product code OJN·July 7, 2022
T-SPOT.TB REF TB.300 US
FDA Recall
Open, Classified
·OXFORD IMMUNOTEC LTD
143 Park Road
Abingdon United Kingdom·Product code OJN·July 7, 2022
AIM-V Medium REF AV.200/500
FDA Recall
Open, Classified
·OXFORD IMMUNOTEC LTD
143 Park Road
Abingdon United Kingdom·Product code OJN·July 7, 2022
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 Recall
Terminated
·Oxford Immunotec·Product code OJN·July 16, 2020
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 Recall
Terminated
·Oxford Immunotec·Product code OJN·July 16, 2020
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