MedicalSystem Biotechnology obtains Zhejiang medical device registration certificates for two in vitro diagnostic reagent kits

RegulationProduct / Tech
โดย Jiemian·CN·Read original
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MedicalSystem Biotechnology Co., Ltd., stock code 300439 on the Shenzhen Stock Exchange, announced on September 10 that it recently obtained two Medical Device Registration Certificates for in vitro diagnostic reagents issued by the Zhejiang Medical Products Administration. The Immunoglobulin G4 Assay Kit, using latex immunoturbidimetry, has registration certificate number Zhejiang Medical Device Registration Approval 20262400468, valid from September 7, 2026 to September 6, 2031, and is used for the quantitative in vitro determination of immunoglobulin G4 concentration in human serum. The Ammonia Assay Kit, using the glutamate dehydrogenase method, has registration certificate number Zhejiang Medical Device Registration Approval 20262400475, valid from September 9, 2026 to September 8, 2031, and is used for the quantitative in vitro determination of ammonia concentration in human plasma. The company stated that obtaining these registration certificates enriches its product line in the in vitro diagnostic biochemistry segment, helps enhance its core competitiveness and market expansion capabilities, and will have a positive impact on future operations. The company also cautioned that actual sales will depend on market promotion results, and the specific impact on performance cannot yet be predicted.

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