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 ...

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 ...

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 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 ...

This notification supplements previous Urgent Medical Device Correction (UMDC) communications initially issued by Roche Diagnostics on September 12, 2018 and updated on October 17, 2018. Roche ...

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 ...

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 ...

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 ...

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 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 ...