Alzheimer's Associated Neurofilament Protein (AD7C-NTP) Assay Kit (Magnetic Particle Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- Type I (excluding calibrators and quality controls): 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box. Type II (including calibrator): 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/box. Type III (including calibrator and quality control): 50 servings/box, 100 servings/box, 150 servings/box, 200 servings/boxⅠ型(不含校准品和质控品):50人份/盒、100人份/盒、150人份/盒、200人份/盒。Ⅱ型(含校准品):50人份/盒、100人份/盒、150人份/盒、200人份/盒。Ⅲ型(含校准品和质控品):50人份/盒、100人份/盒、150人份/盒、200人份/盒
- Approval department
- Hunan Provincial Drug Administration湖南省药品监督管理局
- Registration number
- 湘械注准20242400019
- Approval date
- January 10, 2024
- Expiry date
- January 09, 2029
- Name
- Hunan Yonghe-sun Biotechnology Co., Ltd.湖南永和阳光生物科技股份有限公司
- Province/Region
- Hunan湖南
- Address
- No. 101, Kangtian Road, Liuyang Economic and Technological Development Zone浏阳经济技术开发区康天路101号
- Production address
- 浏阳经济技术开发区康天路101号
It is used for in vitro quantitative detection of Alzheimer's-related neurofilament protein content in human urine samples.
用于体外定量检测人体尿液样本中的阿尔茨海默相关神经丝蛋白含量。
The product consists of reagent R1, reagent R2, calibrator and quality control. Magnetic separation reagent R1: magnetic particles coated with AD7C-NTP antibody (approximately 0.07 mg/mL); PBS buffer, 10 mmol/L; ProClin 300, 0.5 g/L, Reagent R2: AD7C-NTP-Acridine Ester Label, 3 mg/L, PBS Buffer, 10 mmol/L, ProClin 300, 0.5 g/L, Calibrators: AD7C-NTP Antigen, Mannitol, PBS, Level 1: 0 ng/mL, Level 2: (1-8) ng/mL, Level 3: (8-18) ng/mL, Control: AD7C-NTP Antigen, Mannitol, PBS, Level 1: (1-8) ng/mL, Level 2: (8-18) ng/mL.
产品由试剂R1、试剂R2、校准品、质控品组成。磁分离试剂R1:包被有AD7C-NTP抗体的磁性微粒(约0.07mg/mL);PBS缓冲液,10mmol/L; ProClin 300,0.5g/L;试剂R2:AD7C-NTP-吖啶酯标记物,3mg/L;PBS缓冲液,10mmol/L;ProClin 300,0.5g/L;校准品:AD7C-NTP抗原、甘露醇、PBS,水平1:0ng/mL、水平2:(1-8)ng/mL、水平3:(8-18)ng/mL;质控品:AD7C-NTP抗原、甘露醇、PBS,水平 1:(1-8)ng/mL、水平2:(8-18)ng/mL。
The unopened reagent is stored at 2°C~8°C and has a validity period of 12 months, and the opened reagent is stored at 2°C~8°C and can be stable for 1 month. The unopened calibrators and controls can be stored for 12 months at 2°C~8°C, and the calibrators and controls can be stored at 2°C~8°C for 3 days after reconstitution.
未开封的试剂在2℃～8℃条件下保存，有效期为12个月；开封后的试剂在2℃～8℃条件下保存，可稳定1个月。未开封校准品、质控品2℃～8℃条件下，可保存12个月；校准品、质控品复溶后， 2℃～8℃条件下保存，可稳定3天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Alzheimer's Associated Neurofilament Protein (AD7C-NTP) Assay 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20242400019 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on January 10, 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.