Glutamate dehydrogenase assay kit (α-Ketoglutaric acid substrate method) - NMPA Registration 川械注准20232400407
Access comprehensive regulatory information for Glutamate dehydrogenase assay kit (α-Ketoglutaric acid substrate method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20232400407 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on November 28, 2023.
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In vitro quantitative determination of glutamate dehydrogenase activity in human serum and human plasma samples.
体外定量测定人血清、人血浆样本中谷氨酸脱氢酶的活性。
See attached page II
见附页二
The validity period of the reagent is 18 months when stored at 2°C~8°C and protected from light, and it can be stable for 14 days when the bottle is opened and stored at 2°C~8°C. After reconstitution, the calibrator and quality control can be stable for 2 days when stored in the dark at 2°C~8°C, and can be stored at -20°C for 1 week, and cannot be frozen and thawed repeatedly.
试剂2℃～8℃密闭避光贮存有效期为18个月，开瓶上机2℃～8℃避光贮存可稳定14天。校准品、质控品复溶后2℃～8℃避光贮存可稳定2天，-20℃保存可稳定1周，不可反复冻融。