Co-Diagnostics secures CE Mark for its Logix Smart COVID-19 coronavirus PCR test.
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Published:27th Feb 2020
Co-Diagnostics, Inc. a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced that its Logix Smart Coronavirus COVID-19 Test has obtained regulatory clearance to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of SARS-CoV-2 (COVID-19) in markets that accept CE-marking as valid regulatory approval, and is now available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility. The Declaration of Conformity for the Logix Smart COVID-19 test confirms that it meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD to commence immediately in the European Community. Co-Diagnostics shipped samples of the Research Use Only version of its test to distributors in Italy and Germany last week, which allowed future customers to confirm the quality and sensitivity of the product prior to the IVD being available, and the Company to accelerate the sales efforts of its diagnostic. Many other global markets also accept a CE marking as valid regulatory approval following routine local product registration, which allows sales of the Company’s IVD into these areas.