Enigma Diagnostics said this week that it has received CE IVD marking for its Enigma ML system and first assay, a combined molecular test for influenza A/B and respiratory syncytial virus.

The CE mark is an important milestone for Salisbury, UK-based Enigma, which has been developing the Enigma ML (Mini Laboratory) — a real-time PCR-based point-of-care testing platform — since at least 2009. Enigma said that it will now begin marketing its system and FluAB-RSV assay in more than 30 countries recognizing the CE mark.

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