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达安基因(002030.SZ)子公司获得一项医疗器械注册证

daan gene co.,ltd. (002030.SZ) subsidiary has obtained a medical instruments registration certificate.

Zhitong Finance ·  Oct 7, 2024 15:59

daan gene co.,ltd. (002030.SZ) announced that its wholly-owned subsidiary, Guangzhou Datai Bioengineering Technology Co., Ltd...

Zhichong Finance and Economics APP News, daan gene co.,ltd. (002030.SZ) announced that its wholly-owned subsidiary, Guangzhou Datai Bioengineering Technology Co., Ltd., has obtained a medical device registration certificate issued by the National Medical Products Administration for a medical instrument named Alpha-fetoprotein Assay Kit (latex enhanced immunoturbidimetric method), registration number: NMPA Registration 20243401944. The validity period is from the date of approval until September 28, 2029.

Intended use: This assay kit is used for the quantitative determination of Alpha-fetoprotein (AFP) in human serum or plasma samples. Mainly used for dynamic monitoring of malignant tumor patients to assist in determining the disease progression or treatment effect. It cannot be used as the basis for early diagnosis or definitive diagnosis of malignant tumors and is not for general population tumor screening.

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