National Institute for Health and Care Excellence

Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial ...
Monthly Prescribing Reference

FDA Grants CLIA-waived status to CoaguChek XS Plus system

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 ...
Medindia

New Handheld Base Unit for CoaguChek XS Plus System Enables Connectivity to RALS-Plus Data Management Solution for PT/INR Testing at the Point of Care

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 ...
News Medical

Roche Diagnostics' CoaguChek XS Plus system granted CLIA-waived status

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 ...
News Medical

Roche receives FDA 510(k) clearance for CoaguChek XS Pro point-of-care anticoagulation monitor

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 ...
FiercePharma

FDA grants CLIA-waived status to CoaguChek XS Plus system for PT/INR testing at the point of care

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 ...
Pharmabiz

US FDA clears Roche's CoaguChek XS Pro system with bar code reader for PT/INR testing at the point of care

Roche Diagnostics announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the CoaguChek XS Pro system, a new point-of-care anticoagulation monitor with a ...
Monthly Prescribing Reference

FDA: Class I Recall of Test Strips Due to Inaccurate INR Results

Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled. Roche Diagnostics has issued a recall of certain lots of CoaguChek XS PT Test Strips, ...
Medscape

FDA: Class I Recall of Roche Warfarin Test Strips for INR Monitoring

A voluntary recall of certain test strips made by Roche Diagnostics for use with its CoaguChek warfarin anticoagulation meters is now categorized as Class I, the US Food and Drug Administration has ...
Medindia

FDA grants CLIA-waived Status to CoaguChek XS Plus System for PT/INR Testing at the Point of Care

INDIANAPOLIS, March 30 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 ...