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Shengxiang Bio (688289.SH) announced that the company’s wholly-owned subsidiary Hunan Shengwei Gene Technology Co., Ltd. products hepatitis B virus, hepatitis C virus, human immunodeficiency virus (type 1+2) nucleic acid detection kits ( PCR-fluorescence method) has recently obtained the EU CE certification (IVDD List Class A).
The kit can be used for blood source screening. One tube of detection can distinguish hepatitis B, hepatitis C and HIV. Through high-precision and automated solutions, it can help global blood safety and hospital infection prevention and control. This is the fourth EU CE List A certification obtained by the company and its wholly-owned subsidiaries after the three nucleic acid detection products of hepatitis B, hepatitis C and AIDS. Among the EU CE certification categories, List A products are subject to the highest degree of regulatory supervision. , the technical requirements are strict, the verification, evaluation and auditing required are relatively high, and the certification is difficult. Obtaining this certification fully reflects the company’s R&D innovation strength, product quality and reliable performance.
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