OFY - BEUDAMED

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

The Orthotic Group, Inc.

Manufacturer

🇨🇦 Canada

Prollenium Medical Technologies Inc.

Manufacturer

🇨🇦 Canada·32 Basic UDI-DIs·32 Devices·1 Importer·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, and NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY

Delfi Medical Innovations Inc.

Manufacturer

🇨🇦 Canada·20 Basic UDI-DIs·30 Devices·2 Importers·National Standards Authority of Ireland (NSAI)