The PerkinElmer® COVID-19 Antigen Test has been approved by the National Sanitary Surveillance Agency of Brazil (ANVISA) as a Class III in vitro diagnostic (IVD) device; ANVISA Registration No: 10298910160. This approval authorizes the importation, sale, distribution, and use of PerkinElmer’s 15-minutes antigen test in Brazil for the qualitative detection of SARS-CoV-2, with nasal or nasopharyngeal swabs. The PerkinElmer® COVID-19 Antigen test is an accurate and efficient product to screen for the presence of COVID-19.
As of mid-July, Brazil is leading the world in the number of new cases of the Coronavirus according to the WHO (WHO Coronavirus (COVID-19) Dashboard, July, 16, 2021). The ANVISA approval of the PerkinElmer® COVID-19 Antigen Test kit enables PerkinElmer to help Brazil strategically combat the SARS-CoV-2 virus by quickly and accurately determining if someone is infected, hence allowing Brazil to reduce the spread of COVID-19.
The ANVISA approval will allow PerkinElmer to sell these test kits in Brazil for at least 10 years. Furthermore, the ANVISA certification status will allow PerkinElmer to use Brazil as reference in some countries to speed up approval of this product.
In addition, Tulip, Zephyr Biomedicals site, which manufactures the PerkinElmer® COVID-19 Antigen Test kit; had its GMP certification approved by ANVISA.
Learn more about the PerkinElmer® COVID-19 Antigen .