High-density lipoprotein cholesterol (HDL-CHO) detection kit (direct method-selective inhibition method) - NMPA Registration 京械注准20222400293
Access comprehensive regulatory information for High-density lipoprotein cholesterol (HDL-CHO) detection kit (direct method-selective inhibition 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20222400293 and owned by Beijing Baiao Taikang Biotechnology Co., Ltd.. The device was approved on July 22, 2022.
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For the quantitative determination of the concentration of HDL cholesterol in human serum in vitro.
用于体外定量测定人血清中高密度脂蛋白胆固醇的浓度。
Composition Concentration Reagent 1 R1 MOPS buffer (20.0-200 mmol/L, PH 6-8) Peroxidase (POD) TOOS ≥ 10.0 KU/L ≥ 0.2 mmol/L REAGENT 2 R2 MOPS buffer (20.0-200 mmol/L, PH6-8) Cholesterase, Cholesterol oxidase, Peroxidase (POD), 4-AMINOANTIPYRINE ≥0.5KU/L ≥0.5KU/L 10.0KU/L 2. 0mmol/L Calibrator (optional) Lyophilized Bovine serum HDL cholesterol ≥20% Target concentration: 1.50mmol/L Quality Control Low value (optional) Lyophilized Bovine serum HDL cholesterol ≥20% Target concentration range: (0.63-1.17)mmol/L Quality control high value (optional) Freeze-dried bovine serum HDL cholesterol ≥20% Target concentration range: (0.84-1.56)mmol/L The target value of the calibrator and the quality control range have lot specificity, see bottle label for details.
成分 浓度 试剂1 R1 MOPS缓冲液（20.0-200mmol/L，PH 6-8） 过氧化物酶(POD) TOOS ≥10.0KU/L ≥0.2mmol/L 试剂2 R2 MOPS缓冲液（20.0-200mmol/L，PH 6-8） 胆固醇酯酶 胆固醇氧化酶 过氧化物酶(POD) 4-氨基安替比林 ≥0.5KU/L ≥0.5KU/L 10.0KU/L 2.0mmol/L 校准品 (选配) 冻干 牛血清 高密度脂蛋白胆固醇 ≥20% 目标浓度:1.50mmol/L 质控品 低值 (选配) 冻干 牛血清 高密度脂蛋白胆固醇 ≥20% 目标浓度范围:(0.63-1.17)mmol/L 质控品 高值 (选配) 冻干 牛血清 高密度脂蛋白胆固醇 ≥20% 目标浓度范围:(0.84-1.56)mmol/L 校准品靶值、质控品质控范围具有批特异性，详见瓶签。
2 °C ~ 8 °C sealed and protected from light, the validity period is 18 months
2℃～8℃密封避光贮存，有效期为18个月