25-Hydroxyvitamin D (25-OH-VD) Assay Kit (Magnetic Particle Chemiluminescence Method)
- Device class
- Class II
- Model specifications
- 50 servings/box, 100 servings/box, 2×100 servings/box, 5×100 servings/box, calibrator: 2×0.5 mL (2 levels, optional), Control: 2×0.5 mL (2 levels, optional).50人份/盒、100人份/盒、2×100人份/盒、5×100人份/盒、校准品：2×0.5 mL（2个水平，选配）、质控品：2×0.5 mL（2个水平，选配）。
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252400077
- Approval date
- January 14, 2025
- Expiry date
- January 13, 2030
- Name
- Shenzhen AmTech Bioengineering Ltd,Inc深圳上泰生物工程有限公司
- Province/Region
- Guangdong广东
- Address
- 901, Building A1A2, Building A1, Building A1, Guangming Science and Technology Park, Phoenix Community Tourist Road, Guangming District, Shenzhen深圳市光明区凤凰街道凤凰社区观光路招商局光明科技园A1A2栋A1栋901
- Production address
- 深圳市光明区凤凰街道凤凰社区观光路招商局光明科技园A1A2栋A1栋901、1001、1101
It is used for the quantitative detection of 25-hydroxyvitamin D content in human serum in vitro, and is mainly used clinically for the auxiliary diagnosis of vitamin D deficiency-related diseases.
用于体外定量检测人血清中25-羟基维生素D的含量，临床上主要用于维生素D缺乏相关疾病的辅助诊断。
试剂盒由链霉亲和素磁珠试剂、吖啶标记物试剂、生物素化25-羟基维生素D试剂、解离剂、校准品（2个水平，选配）、质控品（2个水平，选配）组成，主要成分如下： 1.链霉亲和素磁珠试剂：Tris，BSA，链霉亲和素包被的磁珠。 2.吖啶标记物试剂：PBS，BSA，吖啶标记的25-羟基维生素D抗体（CHO细胞重组表达）。 3.生物素化25-羟基维生素D试剂：Tris，BSA，DMSO，生物素化25-羟基维生素D。 4.解离剂：PBS。 5.校准品（2个水平，选配）、质控品（2个水平，选配）：MES，BSA，25-羟基维生素D。
本试剂盒在2～8℃避光贮存，禁止冷冻，有效期为12个月。试剂开封在机2～15℃可稳定28天。 校准品和质控品在2～8℃避光贮存，有效期为12个月。校准品、质控品开瓶后20～25℃可稳定8小时；2～8℃可稳定28天。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 25-Hydroxyvitamin D (25-OH-VD) 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 粤械注准20252400077 and owned by Shenzhen AmTech Bioengineering Ltd,Inc. The device was approved on January 14, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.