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 ...
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

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 ...
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 ...
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 ...
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)

The National Institute for Health and Care Excellence (NICE) is producing guidance on using the CoaguChek XS system and the INRatio2 PT/INR monitor in the NHS in England. The Diagnostics Advisory ...
FierceBiotech

Roche debuts iOS app for blood coagulation test device

Roche unveiled a new app for patients on anticoagulation therapy, allowing them to see results from their at-home blood clotting tests on an iOS device. The app connects via Bluetooth to the CoaguChek ...
Pharmabiz

Roche Diagnostics, Eisai & EIDIA to launch self-testing coagulation analyzer, CoaguChek XS Personal in Japan

Roche Diagnostics KK together with Eisai Co., Ltd. and its diagnostics subsidiary EIDIA Co., Ltd. will be launching CoaguChek XS Personal (specially controlled medical device/medical equipment ...
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 ...
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)

The CoaguChek XS system (Roche Diagnostics) comprises a meter and specifically designed test strips that can analyse a blood sample (fresh capillary blood or fresh untreated whole venous blood) and ...