Despite of being a young company, we have managed to fulfill all requirements set out in the European IVD Directive 98/79/EC allowing us to mark our first product SwiftX™ Swabs as CE-IVD device. The product has been registered with the German Regulatory Authority and is now available as an in-vitro-diagnostic device for use in routine diagnostic laboratories.
SwiftX™ Swabs has been developed for processing of dry swabs sampled from the respiratory tract such as nose, nasopharynx, oral cavity or oropharynx. It's easy and rapid workflow makes it a great fit for all laboratories that search for combining the processing speed of extraction-free methods with the RNA and DNA quality of silica-based extraction kits.