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US market expands for Glycosal diabetes test

This article was originally published in Clinica

Executive Summary

Provalis has gained the green light to expand the US market for its Glycosal diabetes test after receiving FDA clearance to sell the test for prescription home use. The US has also granted the product CLIA (Clinical Laboratory Improvement Amendments) waiver status, a regulation designated to diagnostic tests that have been proven to be sufficiently simple and accurate to use, such that erroneous results in the hands of a non-medical user are extremely unlikely.





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