[INQ. NO. 2101C01] RADI COVID-19 Detection Kit is an in vitro diagnostic medical device (IVD), based on real-time RT-PCR technology utilizing reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA). It is intended for the presumptive qualitative detection of nucleic acid from the COVID-19 in upper and lower respiratory specimens.
The RADI COVID-19 Detection Kit is a CE certified product, and achieved the best results in the world with 100% sensitivity and specificity from FIND, which is working in partnership with WHO to accelerate development and access to diagnostics as part of the global response to the COVID-19 pandemic. Also, in December 2020, our kit was selected as a “Next Generation World Class Product” of Korea and certified as a Brand K product.
The biggest advantage of this product is the running time which is only 80 minutes compared to that of other companies, which is mostly 2-3 hours.
Immunoassay Kit for COVID-19 Ag Detection
RADI COVID-19 Ag Rapid Test is a CE certified product that has shown excellent performance in Green Cross Lab, one of the best commercial laboratories in South Korea. This test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swabs from individuals suspected of COVID-19 within 15~30minutes.
KH Medical Co., Ltd., the manufacturer is playing a significant role in the world as a total solution provider of high-quality diagnostics for COVID-19 in full packages.
The company aims to provide equal access to quality healthcare-diagnostics for all people on the planet, and to improve their diagnostic systems through its diagnostic solutions in developing countries, especially the African continent.
KH Medical is certified by the Ministry of Food and Drug Safety (MFDS) and the Good Manufacturing Practice (GMP) in South Korea and by ISO 13485 worldwide. It operates an R&D center officially recognized by Korea’s Ministry of Science and ICT.
In 2020, for its excellent R&D activities on the COVID-19 Detection Kit, the company has been certified by the Korea Enterprise Data as a company with excellent technology for prevention of COVID-19 PCR KIT, selected as Export Frontier Enterprise and received a commendation from the governor of Gyeonggi Province. In December 2020, its product has been selected as a Next Generation World Class Product of Korea and the Brand K.
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