Barrel StatSure Receives FDA CLIA Waiver patented HIV
StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR.OB) announced that the Food and Drug Administration (FDA), through its Center for Devices and Radiological Health, is exempt under the Clinical Laboratory Improvement changes of 1988 ( CLIA approved) for HIV-1 / 2 rapid tests using cane Companys patented. The product of HIV 1 / 2 is marketed and distributed worldwide by Inverness Medical Innovations (Amex: IMA) under its Clearview (R) brand as Clearview COMPLETE HIV 1 / 2In particular, the test has been waived for use in detecting antibodies to HIV-1 and HIV-2 in human blood serum and plasma, and demonstrates a sensitivity of 99.7% and a specificity of 99, 9% in clinical studies. With this waiver, the CLEARVIEW (R) HIV-1 / 2 test can be used by more than 189,000
sites in the United States, including the clinical knowledge, community organizations and medical offices. StatSures barrel patented technology is designed to maximize safety, comfort, performance and service life and minimize exposure to infectious agents.Steve Peltzman, CEO of StatSure said: We are very pleased with this result and the underlying markets that trade can now be pursued. StatSure hopes to exploit what was the format properties to develop and commercialize additional point-of-care rapid tests for other infectious diseases. ABOUT STATSURE StatSure Diagnostic Systems, Inc.
Diseases, in addition, the company has developed and patented a range of oral-fluid collection devices on the market. The Companys proprietary platforms provide significant customer
benefits and competitive advantages of similar products that are currently available for comparison. Improved accuracy, operator convenience and reduced risk of infection from collecting and processing the samples have been developed into products of SDS.Technology platform for the development of future products. Some of these products are the United States and internationally sold to various distributors for use
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