581 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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
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
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA classification
FDA Class 3
·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
ODNE AG
FDA registration
ODNE AG·4 products·🇨🇭 Switzerland
O.N. DIAGNOSTICS, LLC
FDA registration
O.N. DIAGNOSTICS, LLC·2 products·🇺🇸 United States
Human Power of N
FDA registration
Human Power of N·1 product·🇺🇸 United States
BMT Medizintechnik GmbH
FDA UDI
BMT Medizintechnik GmbH·04251725214487·GINGIVECTOMY KNIFE ORBAN, #1
BMT Medizintechnik GmbH
FDA UDI
BMT Medizintechnik GmbH·04251725214500·GINGIVECTOMY KNIFE ORBAN, DOUBLE, #1/2
BMT Medizintechnik GmbH
FDA UDI
BMT Medizintechnik GmbH·04251725214494·GINGIVECTOMY KNIFE ORBAN, #2
OPN NC
FDA UDI
SIS Medical AG·07640142570639·OPN NC Ø4.0x15 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142570578·OPN NC Ø3.0x15 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142572855·OPN NC Ø1.5x10 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142570530·OPN NC Ø2.5x10 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142570547·OPN NC Ø2.5x15 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142572909·OPN NC Ø4.5x20 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142570516·OPN NC Ø2.0x15 PTCA catheters
OPN NC
FDA UDI
SIS Medical AG·07640142570523·OPN NC Ø2.0x20 PTCA catheters