SD Biosensor is a global medical device manufacturer that provides innovative solutions for diagnosing various diseases, including COVID-19. Their products range from rapid diagnostic kits to automated analyzers, catering to the needs of different healthcare settings.
Founded in 2009 in Korea
Expanded globally with offices in the USA, Europe, and Asia
Received FDA and CE approval for their COVID-19 diagnostic products
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A rapid diagnostic test for detecting SARS-CoV-2 antigen in respiratory samples. It provides results within 30 minutes and has received FDA EUA and CE approval.
A real-time PCR kit for detecting SARS-CoV-2 in respiratory samples. It provides accurate results within 2 hours and has received FDA EUA approval.
An automated analyzer for performing immunological diagnostic tests, including rapid tests and ELISAs. It's compact, easy to use, and provides reliable results.
SD Biosensor is a global medical device manufacturer that provides innovative solutions for diagnosing various diseases, including COVID-19.
SD Biosensor has offices in Korea, the USA, Europe, and Asia.
SD Biosensor offers a range of products, including rapid diagnostic kits, automated analyzers, and PCR kits for detecting various diseases.
Yes, SD Biosensor has received FDA EUA approval for their COVID-19 diagnostic products, including the Standard Q COVID-19 Ag rapid antigen test and STANDARD M nCoV Real-Time Detection kit.
Based on clinical studies, the Standard Q COVID-19 Ag rapid antigen test has a specificity of 99.3% and a sensitivity of 96.52%. However, the accuracy may vary depending on various factors, such as specimen collection, storage, and handling.