REVEALCOVID-19 Total Antibody Test is also under FDA/EUA review. At the beginning of the month, MedMira made a full EUA submission based on the available FDA guidelines and, since then, has received FDA acknowledgment letter stating that the product’s EUA is under review
MedMira declares conformity to all essential requirements outlined in the In Vitro Diagnostic Medical Devices Directive 98/79/EC. The Certificate of Registration has been obtained from the European Authorized Representative and the product is now registered in the German DIMDI data base as per Directive 98/79/EC of the European Parliament and of the Council of the European Union relating to in vitro diagnostic medical devices.
“The CE Marking announcement made today represents a significant milestone for the Company and our REVEALCOVID-19™ Total Antibody Test,” said Hermes Chan, CEO. “Our RVF-based total antibody test will provide immediate information to physicians and healthcare providers to assess the total antibody status in patients who have been infected with the SARS-CoV-2 virus, the virus that causes COVID-19. Additionally, the unique batch testing capability of the REVEALCOVID-19™ Total Antibody Test would be ideal for the increasing demand for a large screening program developed in many countries.”
REVEALCOVID-19 Total Antibody Test is also under FDA/EUA review. At the beginning of the month, MedMira made a full EUA submission based on the available FDA guidelines and, since then, has received FDA acknowledgment letter stating that the product’s EUA is under review.
The timeline for the EUA approval process is not clearly defined, however, MedMira is committed to meet all FDA requirements in a timely manner. It should further be noted, MedMira has previously received EU (CE mark), FDA (PMA), Health Canada and CFDA (China) approval for its RVF-based Reveal HIV antibody test, as well as EU approval (CE mark) for Multiplo TP/HIV rapid test.
MedMira is a leading developer and manufacturer of vertical flow rapid diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV and Hepatitis C, in just three easy steps.
Source: Company Press Release