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 ...
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 assessment consisted of a systematic review of the evidence on test performance and clinical‑effectiveness data for the CoaguChek XS system, the INRatio2 PT/INR monitor, the ProTime ...
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 ...
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 ...
BioSpace

Roche Receives FDA Clearance for CoaguChek XS Pro System With Bar Code Reader for PT/INR Testing at the Point of Care

INDIANAPOLIS, July 26 /PRNewswire/ -- 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 ...
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 ...
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 ...