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 ...
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

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 ...