Since the inception in November 2013, Biohit Healthcare (Hefei) Co., Ltd. has been committed to the R&D and application of in vitro diagnostic (IVD) devices and supporting instruments. They have obtained ISO 13485 Quality Management System certification and the Medical Device Production License.
Since the outbreak of COVID-19 in early 2020, Biohit (Hefei) has proactively participated in combating the pandemic. Based on previous technology development in the IVD industry, they have developed a number of COVID-19 antigen and antibody tests. The antibody test has been granted EUA by the US-FDA and the antigen blood test is the first of its kind in the world.
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