This resource has been developed to provide practical information and advice on self-monitoring coagulation status using a point-of-care coagulometer (the CoaguChek XS system) for people having ...

INDIANAPOLIS, Nov. 11 The U.S. Food and DrugAdministration has granted approval for the new Handheld Base Unit for theCoaguChek(R) XS Plus System, which provides connectivity between ...

Roche Diagnostics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CoaguChek® XS Pro system, a new point-of-care anticoagulation monitor with a ...

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy INDIANAPOLIS, Oct. 1, 2012 ...

COAGUCHEK XS PLUS SYSTEM anticoagulation monitor by Roche Roche announced that it has been granted CLIA-waived status by the FDA for the CoaguChek XS Plus system, a point-of-care anticoagulation ...

Roche Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care anticoagulation monitor that offers ...

This notification supplements previous Urgent Medical Device Correction (UMDC) communications initially issued by Roche Diagnostics on September 12, 2018 and updated on October 17, 2018. Roche ...