Biochemical multiple composite calibration solution - NMPA Registration 苏械注准20242400176
Access comprehensive regulatory information for Biochemical multiple composite calibration solution in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20242400176 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on February 05, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
Used for the calibration of clinical testing systems for the following biochemical items: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl aminotransferase, cholinesterase, total protein, albumin, total bilirubin, direct bilirubin, lactate dehydrogenase, α-hydroxybutyrate dehydrogenase, creatine kinase, creatine kinase isoenzyme, leucine aminopeptidase, uric acid, urea, creatinine, triglycerides, total cholesterol, glucose, α-amylase, lipase, unsaturated iron-binding, calcium, magnesium, iron, inorganic phosphorus.
用于以下生化项目临床检测系统的校准：丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、碱性磷酸酶、γ-谷氨酰氨基转移酶、胆碱酯酶、总蛋白、白蛋白、总胆红素、直接胆红素、乳酸脱氢酶、α-羟丁酸脱氢酶、肌酸激酶、肌酸激酶同工酶、亮氨酸氨基肽酶、尿酸、尿素、肌酐、甘油三酯、总胆固醇、葡萄糖、α-淀粉酶、脂肪酶、不饱和铁结合力、钙、镁、铁、无机磷。
The product is lyophilized, consisting of bovine serum, buffer stabilizer (20mmol/L Hepes buffer, 1.5% mannitol, 3% trehalose, 0.2% Tween-20, 1% complex enzyme stabilizer AES, 0.1% Proclin300), and the analytical substances of specific items are added, as follows: Alanine aminotransferase (pig heart) 80~240U/L, aspartate aminotransferase (pig heart) 80~240U/L, Alkaline phosphatase (calf intestine) 180~400U/L, γ-glutamylaminotransferase (porcine kidney) 100~250U/L, cholinesterase (horse serum) 4500~10000 U/L, total protein (bovine serum) 50~90g/L, albumin (bovine serum) 30~60g/L, total bilirubin 60~160μmol/L, direct bilirubin 20~60μmol/L, lactate dehydrogenase (rabbit muscle) 230~430 U/L, α-hydroxybutyrate dehydrogenase 250~450 U/L, Creatine kinase (rabbit muscle) 250~600U/L, Creatine kinase isoenzyme (human) 80~150U/L, Leucine aminopeptidase (porcine kidney) 20~50U/L, Uric acid 300~600μmol/L, Urea 10~25mmol/L, Creatinine 250~500 μmol/L, Triglycerides 1.5~3.5mmol/L, Total cholesterol 3.8~8.0mmol/L, Glucose 10~20mmol/ L, α-Amylase (Bacillus subtilis) 180~400U/L, lipase (porcine pancreas) 60~160U/L, unsaturated iron binding capacity 35~65μmol/L, calcium 2.0~4.0mmol/L, magnesium 1.0~2.0mmol/L, iron 30~50μmol/L, inorganic phosphorus 1.5~3.2mmol/L
该产品为冻干品，由牛血清、缓冲稳定剂（20mmol/L Hepes缓冲液、1.5%甘露醇、3%海藻糖、0.2%吐温-20、1%复合酶稳定剂AES、0.1%Proclin300）组成，并添加了特定项目的分析物质，具体内容如下： 丙氨酸氨基转移酶（猪心脏） 80~240U/L、天门冬氨酸氨基转移酶（猪心脏） 80~240U/L、碱性磷酸酶（小牛肠）180~400U/L、γ-谷氨酰氨基转移酶（猪肾脏） 100~250U/L、胆碱酯酶（马血清） 4500~10000 U/L、总蛋白（牛血清） 50~90g/L、白蛋白（牛血清） 30~60g/L、总胆红素 60~160μmol/L、直接胆红素 20~60μmol/L、乳酸脱氢酶（兔肌） 230~430 U/L、α-羟丁酸脱氢酶 250~450 U/L、肌酸激酶（兔肌） 250~600U/L、肌酸激酶同工酶（人源） 80~150U/L、亮氨酸氨基肽酶（猪肾脏） 20~50U/L、尿酸 300~600μmol/L、尿素10~25mmol/L、肌酐 250~500 μmol/L、甘油三酯 1.5~3.5mmol/L、总胆固醇 3.8~8.0mmol/L、葡萄糖 10~20mmol/L、 α-淀粉酶（枯草杆菌） 180~400U/L、脂肪酶（猪胰腺） 60~160U/L、不饱和铁结合力 35~65μmol/L、钙 2.0~4.0mmol/L、镁 1.0~2.0mmol/L、铁 30~50μmol/L、无机磷 1.5~3.2mmol/L
1. The product is stored at 2°C~8°C in the dark, and the validity period is 24 months. 2. After reconstitution, store at 2°C~8°C in the dark, which can be stable for 1 day, and store at 15°C~25°C after reconstitution, and be stable for 2 hours. 3. The production date and expiration date are shown on the label.
1.该产品2℃~8℃避光保存，有效期24个月。 2.复溶后2℃~8℃避光保存，可稳定1天；复溶后15℃~25℃避光保存，可稳定2小时；不可冻融一次。 3.生产日期及失效日期见标签。