Food-Specific IgG4 Antibody Detection Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 湘械注准20242400231
Access comprehensive regulatory information for Food-Specific IgG4 Antibody Detection Kit (Magnetic Particle Chemiluminescence 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 湘械注准20242400231 and owned by Hunan XieGuang Biotechnology Co., Ltd.. The device was approved on March 25, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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.
This kit is used for in vitro qualitative detection of human serum, Foods specific to the plasma sample (e.g. beef/lamb/pork/chicken/turkey/buckwheat/oats/rye/barley/rice/millet/corn/wheat/sesame/malt/milk/buffalo milk/skimmed milk powder/boiled milk/hydrolyzed milk powder/α-whey protein/β-lactoglobulin/casein/cheddar/cottage cheese/buttermilk/yogurt/goat's milk/egg/egg white/egg yolk/ovomucin/salmon/sardines/grass carp/hairtail/scallops/clams/oysters/trout/tuna/lobster/ Cod / Crab / Shrimp / Cashew / Almond / Sunflower Seed / Peanut / Hazelnut / Black Walnut / Watermelon / Olive / Blueberry / Pineapple / Orange / Peach / Apple / Durian / Mango / Banana / Cantaloupe / Grape / Grapefruit / Grapefruit / Strawberry / Lemon / Bok Choy / Soybean / Carrot / Eggplant / Pumpkin / Celery / Parsley / Mushroom / Cucumber / Tomato / Potato / Sweet Potato / Green Bean / Pea / Spinach / Cauliflower / Broccoli / Lettuce / Cabbage / Green Pepper / Onion / Garlic / Green Onion / Coriander / Red Pepper / Mustard / Cane Sugar / Honey / Tea / coffee/chocolate/yeast/cinnamon/butter).
本试剂盒用于体外定性检测人血清、血浆样本中针对食物（如牛肉/羊肉/猪肉/鸡肉/火鸡/荞麦/燕麦/黑麦/大麦/大米/小米/玉米/小麦/芝麻/麦芽/牛奶/水牛牛奶/脱脂奶粉/煮过的牛奶/水解奶粉/α-乳清蛋白/β-乳球蛋白/酪蛋白/切达干酪/白软干酪/酪乳/酸奶/羊奶/鸡蛋/鸡蛋白/鸡蛋黄/卵类粘蛋白/三文鱼/沙丁鱼/草鱼/带鱼/扇贝/蛤/牡蛎/鳟鱼/金枪鱼/龙虾/鳕鱼/螃蟹/虾/腰果/杏仁/葵花籽/花生/榛子/黑胡桃/西瓜/橄榄/蓝莓/菠萝/橘子/桃/苹果/榴莲/芒果/香蕉/哈密瓜/葡萄/柚子/草莓/柠檬/小白菜/大豆/胡萝卜/茄子/南瓜/芹菜/欧芹/蘑菇/黄瓜/西红柿/马铃薯/甘薯/青豆/豌豆/菠菜/菜花/西兰花/生菜/卷心菜/青椒/洋葱/大蒜/大葱/香菜/红辣椒/芥末/蔗糖/蜂蜜/茶/咖啡/巧克力/酵母/肉桂/黄油）的特异性IgG4抗体水平。
The product is composed of R1, M, R2, calibrators, quality controls, and calibration curve reagents, and the specific components are shown in the attached page.
产品由R1、M、R2、校准品、质控品、定标曲线试剂组成，具体组成成分见附页。
The unopened kit is stored in a closed and protected manner at 2 °C ~ 8 °C for 18 months, and it can be stable for 56 days after opening the bottle at 2 °C ~ 8 °C in the dark. Transportation and storage should be carried out under low temperature conditions of 2 °C ~ 8 °C.
未开瓶试剂盒于2℃～8℃密闭避光保存有效期为18个月，开瓶后2℃～8℃避光保存可稳定56天。运输和保存均应在2℃～8℃低温条件下进行。