The Paul-Ehrlich-Institut, also known as the German Federal Institute for Vaccines and Biomedicine, is currently part of the Federal Ministry of Health and is a federal research institute and medical regulatory agency in Germany. Although it is part of the German Ministry of Health, it has independent functions such as biologics testing, clinical trial approval, product approval for marketing and approval for issuance. It also provides professional advice and information to patients and consumers for the German government, local agencies, and parliament.

The COVID-19 IgG/IgM Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.