a-L-Fucosidase Detection Kit (CNPF Substrate Method)
- Device class
- Class II
- Model specifications
- 试剂1:1;40ml,质控品:2;1ml;试剂1:2;40ml;试剂1:1;60ml,质控品:2;1ml;试剂1:2;60ml;试剂1:6;60ml,质控品:2;1ml;试剂1:4;60ml;试剂1:6;100ml,质控品:2;1ml;试剂1:2;20ml;试剂1:1;20ml,质控品:2;1ml;试剂1:5;24ml;试剂1:1L;试剂1:5L.试剂1：1;40ml,质控品：2;1ml;试剂1：2;40ml;试剂1：1;60ml,质控品：2;1ml;试剂1：2;60ml;试剂1：6;60ml,质控品：2;1ml;试剂1：4;60ml;试剂1：6;100ml,质控品：2;1ml;试剂1：2;20ml;试剂1：1;20ml,质控品：2;1ml;试剂1：5;24ml;试剂1：1L;试剂1：5L。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400449
- Approval date
- February 04, 2025
- Expiry date
- February 03, 2030
- Name
- Beijing Homa Biological Engineering Co., Ltd.北京豪迈生物工程股份有限公司
- Province/Region
- Beijing北京
- Address
- East of the first and third floors of Building 7, No. 28 Yuhua Road, Linkong Economic Core Zone, Shunyi District, Beijing北京市顺义区临空经济核心区裕华路28号7号楼一层、三层东侧
- Production address
- 北京市顺义区临空经济核心区裕华路28号7号楼一层、三层东侧
该产品用于体外定量测定人血清中alpha;-L-岩藻糖苷酶(AFU)的活性.
该产品用于体外定量测定人血清中alpha;-L-岩藻糖苷酶(AFU)的活性。
试剂1(R)组成:柠檬酸缓冲液、2-氯-4-硝基苯-a-L-岩藻吡喃糖苷、乙二胺四乙酸二钠;质控品(液体)组成:质控品(水平1):柠檬酸缓冲液、a-L-岩藻糖苷酶;质控品(水平2):柠檬酸缓冲液、a-L-岩藻糖苷酶.
试剂1（R）组成：柠檬酸缓冲液、2-氯-4-硝基苯-a-L-岩藻吡喃糖苷、乙二胺四乙酸二钠；质控品（液体）组成：质控品（水平1）：柠檬酸缓冲液、a-L-岩藻糖苷酶；质控品（水平2）：柠檬酸缓冲液、a-L-岩藻糖苷酶。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for a-L-Fucosidase Detection Kit (CNPF Substrate 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 京械注准20242400449 and owned by Beijing Homa Biological Engineering Co., Ltd.. The device was approved on February 04, 2025.
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