YHLO Rapid Antigen Test Kits Approved by BfArM

2021-04-20

Summary:

YHLO GLINE-2019-nCoV Rapid Antigen Test Kit (professional use) was granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) in Germany.

(Source:https://antigentest.bfarm.de/ords/f?p=101:100:14230378818492:::::)

GLINE-2019-nCoV Ag assay is a colloidal gold immunoassay for the rapid qualitative determination of nucleocapsid protein of SARS-CoV-2 in human nasal or nasopharyngeal swab. The rapid antigen test is easy to operate compared with PCR testing. By following simple instructions, the results would be obtained in 15 minutes without any electronic equipment.

About YHLO

YHLO (EST. 2008) is an innovative and steadfastly growing company headquartered in Shenzhen, China.

To be a reliable and respected IVD enterprise, YHLO has put extensive investments in R&D and firmly associated with the top-tier universities, medical schools and research institutes worldwide on scientific studies. With over a decade's continuous development expertise in immunoassays solution, YHLO provides a broad range of instruments (based on Chemiluminescence, ELISA, Immunoblot and Immunofluorescence methodologies) with patented technologies and outstanding features, as well as a comprehensive total solutions with portfolios in fertility and reproductive health, diabetes, infectious diseases, autoimmune disorders and other novel assays on rare diseases analysis. Since the Covid-19 pandemic outbreak, YHLO has taken a fast response and launched series of assays to assist people around the world in large scale screening test.

Thanks to its premium quality management, YHLO has complied by international standards, ISO 9001:2015, ISO 13485:2016, KGMP of Korea, TGA of Australia, etc. To date, YHLO has a global presence by over 85 countries around the world, our strategic alliances with multinational corporations enable us to be more competitive. Moreover, YHLO has in-depth cooperation with global research partners in Europe, USA, Japan and Australia, with aim of developing advanced technologies and create more medical value for health and vitality of people all over the world.

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