INDIANAPOLIS, Oct. 1, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus ...
The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips ...
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 ...
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 ...
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.
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 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 ...
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 ...
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 ...
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 ...
The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips ...
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