GenStrip™50


compatible with the OneTouch®
Ultra® family of meters

under new quality management

 

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1-844-874-2762

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Indications For Use

GenStrip™ Test Strips with calibration codes 4, 10 and 13 are for use with OneTouch® Ultra®, Ultra®2 and UltraMini® Meters purchased before July 2010. They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, forearm or palm. Testing is done outside the body (in vitro diagnostic use). They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. The system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

Information Regarding the Former Shasta Product

The Former Shasta GenStrip Product

PharmaTech Solutions would like to announce a no cost replacement of the GenStrip™ glucose test strips formerly manufactured by Shasta Technologies, LLC. Shasta's test strips were the subject of FDA’s April 29, 2014 safety communication. PharmaTech acquired the GenStrip product in March 2014 from Shasta and will now manufacture them under its quality system. While PharmaTech has always believed the Shasta GenStrip test strips are safe and effective, it has decided to assume responsibility for manufacturing the new test Strips, renamed “GenStrip™50.” Shasta is no longer part of manufacturing the GenStrip product. Should you decide that you want to replace your Shasta GenStrip product, please contact us at quality@pharmatechdirect.com for further information about our 'no questions asked' return and exchange policy.

Click here to read Decision Diagnostics' Response to Last Weeks FDA Transmittal to Shasta

GenStrip Opportunity Expands Under Full Control of DECN's PharmaTech Division