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亚辉龙(688575.SH)取得一项医疗器械注册证

Yahui Long (688575.SH) has obtained a medical instruments registration certificate.

Zhitong Finance ·  Oct 25 09:51

Yahuilong (688575.SH) issued an announcement. The company recently received an issuance from the Guangdong Drug Administration...

Zhitong Financial App News, Yahuilong (688575.SH) issued an announcement. The company recently received a medical device registration certificate issued by the Guangdong Drug Administration. The product name: anti-SP100IgG antibody test kit (chemiluminescence method) is used to qualitatively detect anti-soluble acidic nucleoprotein IgG antibodies (Sp100IgG) in human serum and/or plasma. Clinically, it is mainly used for auxiliary diagnosis of primary biliary cirrhosis (PBC).

Up to now, the company has obtained 160 domestic “Medical Device Registration Certificates” for chemiluminescence reagents (a total of 229 domestic registration certificates for luminescence reagents). The acquisition of the “Medical Device Registration Certificate” will help further enrich the company's fully automated chemiluminescence product line and improve Yahuilong's testing package in the field of autoimmune liver disease. Up to now, the company has successively obtained 56 domestic “Medical Device Registration Certificates” for chemiluminescence self-exempt reagents.

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