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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