α-L-Fucosidase Assay Kit (CNPF Substrate Method) - NMPA Registration 京械注准20232400560
Access comprehensive regulatory information for α-L-Fucosidase Assay Kit (CNPF 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 京械注准20232400560 and owned by Beijing SenMeiXiKeMa Biotechnology Co., Ltd.. The device was approved on September 13, 2023.
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It is used for the quantitative determination of alpha;-L-fucosidase content in human serum in vitro.
用于体外定量测定人血清中alpha;-L-岩藻糖苷酶的含量。
compose concentration reagent Citric acid buffer (pH 3.0~6.0) 100mmol/L CNPF 5mmol/L calibrators, Lyophilized, 1 level (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L AFU target concentration range (30～75)U/L quality controls, Lyophilized, 2 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L AFU target concentration range Level 1: (20~60) U/L Level 2: (70~140) U/L The target value of the calibrator is batch-specific, see the target value list for details. The quality control quality control range is batch-specific, see the target value list for details.
组成 浓度 试剂 柠檬酸缓冲液(pH 3.0～6.0) 100mmol/L CNPF 5mmol/L 校准品， 冻干,1水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L AFU目标浓度范围 （30～75）U/L 质控品， 冻干,2水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L AFU目标浓度范围 水平1：（20～60）U/L 水平2：（70～140）U/L 校准品靶值批特异，详见靶值单。质控品质控范围批特异，详见靶值单。
Store in the dark under the condition of 2 °C ~ 8 °C, there is
2℃～8℃条件下避光保存，有