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Alzheimer's-Related Neurofilament Protein Test Kit (Dry Fluorescent Immunoassay) - NMPA Registration 苏械注准20232400135

Access comprehensive regulatory information for Alzheimer's-Related Neurofilament Protein Test Kit (Dry Fluorescent 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20232400135 and owned by Lansion Biotechnology Co., Ltd.. The device was approved on January 30, 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.

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NMPA Official Data
Class II
苏械注准20232400135
Alzheimer's-Related Neurofilament Protein Test Kit (Dry Fluorescent Immunoassay)
阿尔茨海默相关神经丝蛋白检测试剂盒(干式荧光免疫层析法)
NMPA Registration Number: 苏械注准20232400135
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Intended Use
English

For the in vitro quantitative detection of the content of Alzheimer's-associated neurofilament protein in human urine.

中文

用于体外定量检测人尿液中阿尔茨海默相关神经丝蛋白的含量。

Device Classification
Device Class
Class II
Model Specifications
General specifications: 1 person/box, 5 people/box, 10 people/box, 20 people/box, 25 people/box, 30 people/box, 50 people/box, 100 people/box; LS-1000/1100/2000/2100/4000/7000/7100 Supporting Packaging Specifications: 1 person/box, 5 people/box, 10 people/box, 20 people/box, 25 people/box, 30 people/box, 50 people/box, 100 people/box; LS-3000/3100/3008/3108/3200/3208/7800/7808 Supporting Packaging Specifications: 1×5 servings/box, 2×5 servings/box, 3×5 people/box, 4×5 people/box, 1×10 people/box, 2×10 people/box, 3×10 people/box, 4×10 people/box, 1×12 people/box, 2×12 people/box, 3×12 people/box, 4×12 people/box, 1×15 people/box, 2 ×15 servings/box, 3×15 servings/box, 4×15 servings/box, 1×20 servings/box, 2×20 servings/box, 3×20 servings/box, 4×20 servings/box, 1×24 servings/box, 2×24 servings/box, 3×24 servings/box, 4×24 people/box, 1×25 people/box, 2×25 people/box, 3×25 people/box, 4×25 people/box, 1×30 people/box, 2×30 servings/box, 3×30 servings/box, 4×30 servings/box, 1×40 people/box, 2×40 people/box, 3×40 people/box, 4×40 people/box, 1×48 people/box, 2×48 people/box, 3×48 people/box, 4×48 people/box.
通用规格:1人份/盒、5人份/盒、10人份/盒、20人份/盒、25人份/盒、30人份/盒、50人份/盒、100人份/盒;LS-1000/1100/2000/2100/4000/7000/7100配套包装规格:1人份/盒、5人份/盒、10人份/盒、20人份/盒、25人份/盒、30人份/盒、50人份/盒、100人份/盒;LS-3000/3100/3008/3108/3200/3208/7800/7808配套包装规格:1×5人份/盒、2×5人份/盒、3×5人份/盒、4×5人份/盒、1×10人份/盒、2×10人份/盒、3×10人份/盒、4×10人份/盒、1×12人份/盒、2×12人份/盒、3×12人份/盒、4×12人份/盒、1×15人份/盒、2×15人份/盒、3×15人份/盒、4×15人份/盒、1×20人份/盒、2×20人份/盒、3×20人份/盒、4×20人份/盒、1×24人份/盒、2×24人份/盒、3×24人份/盒、4×24人份/盒、1×25人份/盒、2×25人份/盒、3×25人份/盒、4×25人份/盒、1×30人份/盒、2×30人份/盒、3×30人份/盒、4×30人份/盒、1×40人份/盒、2×40人份/盒、3×40人份/盒、4×40人份/盒、1×48人份/盒、2×48人份/盒、3×48人份/盒、4×48人份/盒。
Approval Department
Jiangsu Provincial Drug Administration
江苏省药品监督管理局
Registration Information
Registration Number
苏械注准20232400135
Approval Date
January 30, 2023
Expiry Date
January 29, 2028
Registrant
Name
Lansion Biotechnology Co., Ltd.
南京岚煜生物科技有限公司
Province/Region
Jiangsu
江苏
Address
No. 6, Qiande Road, Science Park, Jiangning District, Nanjing
南京市江宁区科学园乾德路6号
Production Facility
Production Address
南京市江宁区科学园乾德路6号第5号楼1层、3号楼一层西侧、3号楼二层西侧、9号楼1层2层
Structure and Composition
English

1. Alzheimer's associated neurofilament protein (AD7c-NTP) reagent card reagent card is composed of reagent strip and shell, of which the reagent strip is composed of the following 4 parts: 1) nitrocellulose membrane: AD7c-NTP 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 AD7c-NTP murine monoclonal antibody 2 (labeled antibody effective content of about 0.14μg/person) and fluorescent microspheres labeled chicken IgY (effective content of labeled antibody is about 0.035μg/person) 3) sample pad 4) absorbent paper 2, other components: instructions, straws (optional), calibration curve (QR code);

中文

1、阿尔茨海默相关神经丝蛋白(AD7c-NTP)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:AD7c-NTP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AD7c-NTP鼠单抗2的荧光微球(标记抗体有效含量约0.14μg/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);

Storage Conditions and Expiration
English

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.

中文

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。