These products are classified as in vitro diagnostic (IVD) medical devices and certified following Directive 98/79/EC.
In the case of rapid swabs and serological swabs for professional use – i.e. intended to be administered by medical/health care personnel – they can be CE marked directly by the manufacturer or importer.
RAPID ANTIGEN SWAB Swabs Rapid antigenic tests look for the surface proteins of the virus (antigens) and not the viral genome (as is the case with [...]
SEROLOGICAL TEST Swabs Rapid qualitative serological tests make it possible to find out if the subject has come into contact with the virus and his immune [...]