Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Roche Says FDA Grants CLIA-waived Status To CoaguChek XS Plus System

Roche (RHHBY.PK) announced Monday that the U.S. Food and Drug Administration or FDA has granted CLIA-waived status to the CoaguChek XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing.

The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments or CLIA of 1988.

The company stated that the CoaguChek XS Plus system offers the ability to connect and transfer data to IT solutions, including TELCOR QML, RALS-Plus with expanded device configuration capabilities or through the POCT1A standard data transfer protocol.

Implementing connectivity with the CoaguChek XS Plus enables data transfer and reporting capabilities to help hospital staff streamline the regulatory compliance process, capture reimbursable costs and improve their organizational efficiency,the company said.

The system uses two-level, built-in quality controls to help ensure the accuracy of PT/INR test results, but also offers optional liquid quality controls for facilities with policies requiring the use of external quality control measures.

Register
To receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
This apparel maker has doubled its earnings per share in just two years and increased its annual earnings forecast from time to time, despite a challenging consumer spending environment. Contributions from acquisitions, efficiency gains from self-owned global supply chain and benefits from 'Innovate-to-Elevate' strategy continue to boost the company's results. Here is a quick summary of the earnings reported after the bell on Nov 20. We have 20+ stocks listed here. The good news is you can skip this step. There is a next move that can make your life a lot easier. Our research team has already done the groundwork for you. All these stocks listed... Design software maker Autodesk, Inc. said Thursday after the markets closed that its third quarter profit fell 81% from last year, as higher costs and expenses more than offset an 11% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.