Human β-amyloid protein 1-42 detection kit (dry fluorescence immunoassay) - NMPA Registration 苏械注准20232400087
Access comprehensive regulatory information for Human β-amyloid protein 1-42 detection kit (dry fluorescence immunoassay) 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20232400087 and owned by Lansion Biotechnology Co., Ltd.. The device was approved on January 13, 2023.
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 suitable for the quantitative detection of human β amyloid 1-42 in human serum in vitro.
适用于体外定量检测人血清中人β淀粉样蛋白1-42的含量。
1. Human β amyloid 1-42 (Aβ1-42) reagent card reagent card is composed of reagent strip and card shell, of which the reagent strip is composed of the following 4 parts: 1) nitrofiber membrane: Aβ1-42 murine monoclonal antibody 1 (effective content of about 0.35μg/person) and sheep anti-chicken IgY (effective content of about 0.35μg/person) 2) binding pad: fluorescent microspheres labeled Aβ1-42 murine monoclonal antibody 2 (labeled antibody effective content of about 0.032μg/person) human serving) and fluorescent microspheres labeled chicken IgY (the effective content of labeled antibodies is about 0.035μg/human serving) 3) Sample pad 4) Absorbent paper 2, other components: instructions, straws (optional), calibration curve (QR code);
1、人β淀粉样蛋白1-42（Aβ1-42）试剂卡试剂卡由试剂条、卡壳组成，其中试剂条由以下4个部分组成：1）硝酸纤维膜：Aβ1-42鼠单抗1（有效含量约0.35μg/人份）和羊抗鸡IgY（有效含量约0.35μg/人份）2）结合垫：标记Aβ1-42鼠单抗2的荧光微球（标记抗体有效含量约0.032μg/人份）和标记鸡IgY的荧光微球（标记抗体有效含量约0.035μg/人份）3）样品垫4）吸水纸2、其他组成：说明书、吸管（选配）、校准曲线（二维码）；
General specifications and LS-1000/1100/2000/2100/4000/7000/7100 supporting packaging specifications: the kit is stored at 4 °C ~ 30 °C, and the validity period is 18 months; The reagent card is individually packaged, and after the strip is opened, it should be used within 1 hour under the condition of 10 °C ~ 30 °C. LS-3000/3100/3008/3108/3200/3208/7800/7808 Supporting Packaging Specifications: The kit is stored at 4 °C ~ 30 °C, and the validity period is 18 months; After the reagent strip is opened, under the condition of 10 °C ~ 30 °C, the cumulative time of exposure to air does not exceed 24 hours, and the unused reagent is recommended to use the packaging bag in the kit to seal and preserve, under the condition of 10 °C ~ 30 °C, the maximum is not more than 15 days.
通用规格及LS-1000/1100/2000/2100/4000/7000/7100配套包装规格：试剂盒在4℃~30℃保存，有效期为18个月；试剂卡为独立包装，卡条开封后，在10℃~30℃条件下应在1小时内使用。LS-3000/3100/3008/3108/3200/3208/7800/7808配套包装规格：试剂盒在4℃~30℃保存，有效期为18个月；试剂条开封后，在10℃~30℃条件下，暴露在空气中的累计时长不超过24小时，未使用完的试剂建议使用试剂盒内的包装袋密封保存，在10℃~30℃条件下，最长不超过15天。