Carcinoembryonic antigen assay kit (latex immunoturbidimetric method) - NMPA Registration 京械注准20232400562
Access comprehensive regulatory information for Carcinoembryonic antigen assay kit (latex immunoturbidimetric 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20232400562 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 the content of carcinoembryonic antigen in human serum in vitro.
用于体外定量测定人血清中癌胚抗原的含量。
compose concentration Reagent 1 Tris buffer (pH 6.0~9.0) 100mmol/L Polyethylene glycol 6000 10g/L Reagent 2 Tris buffer (pH 6.0~9.0) 100mmol/L Polyethylene glycol 6000 10g/L CEA antibody-bound latex particles 0.5% Calibrator Liquid, 6 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L CEA target concentration range Level 1: (0~2)ng/mL Level 2: (5~8)ng/mL Level 3: (11~15) ng/mL Level 4: (23~30)ng/mL Level 5: (48~60)ng/mL Level 6: (95~120) ng/mL Controls Liquid, 2 levels (Optional) Tris buffer (pH 6.0~9.0) 20mmol/L Human serum 300mL/L CEA target concentration range Level 1: (3~7)ng/mL Level 2: (8~20)ng/mL The target lot of the calibrator is specific, see the target value list for details. The quality control and quality control range is specific to the batch, see the target value list for details.
组成 浓度 试剂1 Tris缓冲液(pH 6.0～9.0) 100mmol/L 聚乙二醇6000 10g/L 试剂2 Tris缓冲液(pH 6.0～9.0) 100mmol/L 聚乙二醇6000 10g/L CEA抗体结合的胶乳颗粒 0.5% 校准品 液体,6水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L CEA目标浓度范围 水平1：（0～2）ng/mL 水平2：（5～8）ng/mL 水平3：（11～15）ng/mL 水平4：（23～30）ng/mL 水平5：（48～60）ng/mL 水平6：（95～120）ng/mL 质控品 液体,2水平 （选配） Tris缓冲液(pH 6.0～9.0) 20mmol/L 人血清 300mL/L CEA目标浓度范围 水平1：（3～7）ng/mL 水平2：（8～20）ng/mL 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