On 5th March , Wondfo has completed the application of CE mark for three SARS-CoV-2 antibody rapid tests, making Wondfo the first Chinese medical device company in POCT industry that receives the most CE marks for novel coronavirus antibody test.
The three SARS-CoV-2 antibody rapid tests entitled to CE certificates are:
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method；
FinecareTM SARS-CoV-2 IgM Test
FinecareTM SARS-CoV-2 antibody Test
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG/IgM antibody in human whole blood, serum or plasma sample. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.
The FinecareTM SARS-CoV-2 IgM Test and the FinecareTM SARS-CoV-2 antibody Test are fluorescence immunoassay used along with FinecareTM FIA Meters (Model Code: FS-113, FS-114, FS-205) for qualitative detection of IgG and IgM antibodies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma and whole blood sample. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.
As a leading company of POCT industry, Wondfo has always been devoting ourselves to provide high quality health care service. We have established four global R&D centers (San Diego, Tokyo, Guangzhou and Shenzhen)with more than 450 first-class scientific researchers at home and abroad. To promote a global AI manufacturing system, we have invested in factories in Asia, South America, Africa and the CIS region. Our global marketing service network covers more than 140 countries and regions around the world, furthermore, we keep on in-depth service with establishing more than 20 domestic and foreign subsidiaries.
We strive for excellence to safeguard everyone’s health, and fight against the epidemic!