Germany BfArM PEI Listed

CE Notified Body Certificate 

COVID-19  SARS-CoV-2 Antigen Kit for both Self-testing (zur Eigenanwendung) and Professional Use English Deutsch bilingual packaging

SARS-CoV-2 Antigen Test is used for detection of proteins from the virus that causes COVID-19. A positive result indicates the presence of viral antigens, implying current viral infection. Like RT-PCR test, the antigen test also detects the virus directly, and performs best when the person is tested in the early stages of infection with SARS-CoV-2. The antigen test is very specific, indicating that a positive result is highly accurate. Compared with RT-PCR test, the antigen test is much easier, affordable, and faster. 

In addition, the antigen test can be performed at the point-of-care without the requirements for highly complex instruments and expertise.

FEATURES

• EASY. No special equipment and expertise needed.

• RAPID. Only 12 mins waiting time.

• Nasal swab

• Good correlation with RT-PCR detection.

• Room temperature storage

• Over the counter (OTC) accessible in Germany and Europe. both for professional use and self testing.

• Bfarm Listed in Germany

• Passed PEI evaluation
  

What is PEI 

Germany. PEI (Paul-Ehrlich-Institut) is affiliated to the Federal Ministry of Health. It is the Cooperation Centre of WHO for Quality Assurance of blood products and IVD equipment. The approval of PEI indicates the quality of the product has reachedthe international standard.

Kit components