COVID-19 nucleic acid detection kit
The 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device is a rapid
chromatographic immunoassay for the qualitative detection of IgG & IgM
antibodies for Coronavirus Disease 2019 in human whole blood, serum, or
plasma as an aid in the diagnosis of COVID-19 infections.
SENSO intl limited is diagnostic test company from Hefei city in the province of Anhui, China.
The company has ISO 13485 certification for
the production and distribution of clinical analysers and associated diagnostic
test kits. Their products include rapid test procedures, chemiluminescent systems and PCR technologies.
The IgG / IgM rapid test device described in this document has been developed by the company in response to the outbreak of Covid-19 in China.
The test procedure complies with the EC declaration of conformity in accordance with directive 98/79/EC.