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 ...
Secure online application developed in conjunction with Voluntis helps simplify patient management for physicians and reporting of test results for patients who self-test PT/INR INDIANAPOLIS, Nov. 8, ...
As Pharma giant Roche continues its dive into the digital health realm, it is releasing a new self-testing device for INR or blood coagulation levels, that can wirelessly connect to a smartphone app.
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 ...
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 ...
A new recall has been issued CoaguChek XS PT test strips, used to monitor international normalized ratio (INR) in patients taking warfarin, due to inaccurately high readings. Roche Diagnostics ...
Roche, a global pioneer in pharmaceuticals and diagnostics, has launched the CoaguChek INRange system in countries accepting the CE Mark. The CoaguChek INRange system is the first Bluetooth enabled PT ...
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, ...
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 ...
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 ...
Terrific Care/Medex Supply had purchased these test strips (which were distributed by Roche Diagnostics outside the country) from an unknown source, imported and sold them in the US. The Food and Drug ...
Terrific Care/Medex Supply has announced a recall of all test strips made by Roche Diagnostics for use with its CoaguChek warfarin anticoagulation meters that it has distributed for direct consumer ...
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