6 results
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106ms
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Sources: EU EUDAMED, US FDA
ABBOTT POINT OF CARE CANADA LIMITED
FDA registration
ABBOTT POINT OF CARE CANADA LIMITED·24 products·🇨🇦 Canada
ABBOTT ISTAT
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LIMITED·Product code CGL·June 24, 2020
ABBOTT ISTAT
FDA Adverse Event
Other
·ABBOTT POINT OF CARE CANADA LIMITED·Product code JJY·April 14, 2026
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
FDA Recall
Terminated
·Abbott Point of Care Canada Limited·Product code MMI·November 1, 2012
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
FDA Enforcement
Class II
·Terminated·Abbott Point of Care Canada Limited·January 30, 2013
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices