Food Specific IgG Antibody Detection Test Kit (Enzyme-linked Immunosorbent Assay) - NMPA Registration 苏械注准20172401480
Access comprehensive regulatory information for Food Specific IgG Antibody Detection Test Kit (Enzyme-linked Immunosorbent Assay) 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20172401480 and owned by HOB Biotech Group Corp., Ltd.. The device was approved on July 15, 2022.
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.
It is used for the qualitative detection of food-specific IgG antibodies in human serum (beef, chicken, cod, corn, crab, egg, mushroom, milk, pork, rice, shrimp, soybean, tomato, wheat).
用于定性检测人血清中14种(牛肉、鸡肉、鳕鱼、玉米、蟹、鸡蛋、蘑菇、牛奶、猪肉、大米、虾、大豆、西红柿、小麦)食物特异性IgG抗体。
Microplates coated with food antigens There are 14 food antigens coated, and the types and distribution of antigens are shown in the attached table. 3×96-well sample dilution of the carrier protein dissolved in Tris buffer. 1×56mL standard serum The raw material is derived from human serum and is used to plot the standard curve. 1×1.0mL positive control The raw material is derived from human serum to ensure the effectiveness of the reagent. 1×1.0 mL of concentrated cleaning solution (3:200) Tween dissolved in phosphate buffer. 1×30 mL of enzyme-labeled antibody conjugate Horseradish peroxidase-labeled anti-human IgG antibody and carrier protein were dissolved in Tris buffer. 1×33 mL of substrate solution A tetramethylbenzidine (TMB) was dissolved in citric acid buffer. 2×12 mL of substrate B hydrogen peroxide dissolved in citric acid buffer. 2×12mL stop solution 0.5M sulfuric acid. 1×20mL
包被食物抗原的微孔板 包被有14种食物抗原，抗原种类及分布见附表。 3×96孔样本稀释液 载体蛋白溶于Tris缓冲液中。 1×56mL标准血清 原料来源于人类血清，用于绘制标准曲线。 1×1.0mL阳性对照 原料来源于人类血清，用于确保试剂的有效性。 1×1.0mL浓缩清洗液(3：200) 吐温溶于磷酸盐缓冲液中。 1×30mL酶标抗体结合液 辣根过氧化物酶标记的抗人IgG抗体和载体蛋白溶于Tris缓冲液中。 1×33mL底物液A 四甲基联苯胺(TMB)溶于柠檬酸缓冲液中。 2×12mL底物液B 过氧化氢溶于柠檬酸缓冲液中。 2×12mL终止液 0.5M硫酸。 1×20mL
Under the condition of 2~8°C, the validity period is 18 months.
2～8℃条件下，有效期为18个月。