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Approved for listing | Xinhuan Biotech's new coronavirus lgM antibody detection kit obtains registration certificate
Date：
2020-05-10
source：
Recently, Beijing Xinxing Sihuan Biotechnology Co., Ltd. (hereinafter referred to as: Xinhuan Biotechnology) received the registration certificate for the new coronavirus (2019-nCoV) IgM antibody detection kit issued by the National Medical Products Administration. The kit adopts the detection principle of colloidal gold method, which can interpret the new coronavirus antibody IgM in serum and plasma within 10-15 minutes, adding new force to rapid diagnostic reagents during the epidemic.
| Name | Registration Classification | Registration Number | Validity Period of Registration Certificate |
| Novel coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold method) | Class III | National Machinery Note 20203400457 | 2021.5.7 |
The new coronavirus (2019-nCoV) IgM antibody detection kit (colloidal gold method) certified and marketed by Xinhuan Bio is used for the in vitro qualitative detection of new coronavirus antibody IgM in human serum and plasma samples, and the results are interpreted in 10-15 minutes. Specific antibody detection can be used in conjunction with nucleic acid detection to detect suspected populations to confirm whether there are "asymptomatic infections" or patients in the incubation period, so as to effectively control the spread of the new coronavirus at the source.
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