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BioEcho receives CE-IVD mark approval for SARS-CoV-2 RNA extraction kit – News-Medical.Net

BioEcho Life Sciences announces that the company has recently received CE-mark approval for their EchoLUTION Viral RNA/DNA Swab Kit product line.

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BioEcho Life Sciences announces that the company has recently received CE-mark approval for their EchoLUTION Viral RNA/DNA Swab Kit product line, which has been classified as a medical device Class A IVD in the European Union.
To obtain this certification the products have to comply with the regulation 2017/746 of the European Parliament and of the Council from April 2017 on in vitro diagnostic medical devices (IVDR).
Receiving the CE-IVD mark for our viral RNA and DNA extraction kit does not only…

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