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The  Seralite® – FLC* rapid test complies with Directive 98/79/EC of the European Parliament and the Medical Devices Directive (MDD).

Seralite® – FLC is registered with the UK Notified Body the Medicines and Healthcare Products Regulatory Agency (MHRA) and is designated in the “General” IVDD classification and as such does not require assessment by the Notified Body.

According to the Directive, Seralite® – FLC is in compliance with EC Declaration of Conformity (Annex III) and Essential Requirements (Annex I) and as such the CE Mark can be applied to the in vitro diagnostic device.

A CE mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. It shows that the device is fit for its intended purpose stated and meets legislation relating to safety. It shows the product can be freely marketed anywhere in the European Union without further control.

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*Not available for sale in the USA.