The Seralite® – FLC Serum* rapid test complies with Directive 98/79/EC of the European Parliament and the Medical Devices Directive.
Seralite® – FLC Serum 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 Serum 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 within the European Union.Contact us
*Not available for sale in the USA.