SARS-CoV-2 Antigen Rapid Saliva Test is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in a saliva sample from patients with suspected SARS-CoV-2 infection within the first seven days after the onset of symptoms in vitro.

Please note for the German Market: 

These tests are designed for medical institutions, doctors, healthcare authorities, and other professionals. According to a recent amendment in the Medical Devices Dispensing Ordinance (MPAV – Medizinprodukte-Abgabeverordnung), these testing kits can now also be purchased by private companies, allowing them to provide their employees with proper testing equipment. (For more information see MPAV FAQ and MPAVÄ)

According to the requirements set forth by the Medical Devices Operating Ordinance (MPBetreibV – Medizinprodukte-Betrieberverordnung), point-of-care antigen tests must be performed by persons with the necessary training or knowledge and experience that have been briefed on how to use the test (MPBetreibV § 4, para. 5 in conjunction with para. 2).