Homocysteine (HCY) Determination Reagent Kit (Enzyme Cycling Method)
- Device class
- Class II
- Model specifications
- Reagent 1: 90mL×4, Reagent 2: 90mL×1; Reagent 1: 90mL×4, Reagent 2: 45mL×2; Reagent 1: 60mL×5, Reagent 2: 15mL×5; Reagent 1: 60mL×2, Reagent 2: 15mL×2; Reagent 1: 60mL×1, Reagent 2: 15mL×1; Reagent 1: 60mL×4, Reagent 2: 60mL×1; Reagent 1: 60mL×4, Reagent 2: 30mL×2; Reagent 1: 40mL×2, Reagent 2: 10mL×2; Reagent 1: 40mL×1, Reagent 2: 10mL×1; Reagent 1: 16mL×1, Reagent 2: 4mL×1; Reagent 1: 280mL×1, Reagent 2: 70mL×1; Reagent 1: 4000mL×1, Reagent 2: 1000mL×1; 400 servings (Reagent 1: 64mL×1, Reagent 2: 16mL×1); 1800 servings (Reagent 1: 288mL×1, Reagent 2: 72mL×1); Calibrator (optional): 1mL×1 (2 levels); Control low value (optional): 1mL×1; Control high value (optional): 1mL×1.试剂1:90mL×4，试剂2:90mL×1； 试剂1:90mL×4，试剂2:45mL×2； 试剂1:60mL×5，试剂2:15mL×5； 试剂1:60mL×2，试剂2:15mL×2； 试剂1:60mL×1，试剂2:15mL×1； 试剂1:60mL×4，试剂2:60mL×1； 试剂1:60mL×4，试剂2:30mL×2； 试剂1:40mL×2，试剂2:10mL×2； 试剂1:40mL×1，试剂2:10mL×1； 试剂1:16mL×1，试剂2:4mL×1； 试剂1:280mL×1，试剂2:70mL×1； 试剂1:4000mL×1，试剂2:1000mL×1； 400人份(试剂1:64mL×1，试剂2:16mL×1)； 1800人份(试剂1:288mL×1，试剂2:72mL×1)； 校准品(选配) :1mL×1（2水平）； 质控品低值(选配) :1mL×1；质控品高值（选配）:1mL×1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20222400291
- Approval date
- July 22, 2022
- Expiry date
- July 21, 2027
- Name
- Beijing Baiao Taikang Biotechnology Co., Ltd.北京安图生物工程有限公司
- Province/Region
- Beijing北京
- Address
- Building 17 and Building 18, No. 13 Mintai Road, Beiwu Town, Shunyi District, Beijing (Science and Technology Innovation Functional Area)北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)
- Production address
- 北京市顺义区北务镇民泰路13号院17号楼、18号楼、24号楼（科技创新功能区）
For in vitro quantitative detection of homocysteine concentrations in human serum.
用于体外定量检测人血清中同型半胱氨酸的浓度。
Composition Concentration Reagent 1 R1 NADH DL-Serine ≥0.1mmol/L ≥20mmol/L Reagent 2 R2 Cystathionine-β-synthetase Cystathionine-β-lyase ≥2KU/L ≥2KU/L Calibrator (optional) 2 levels, liquid Phosphate buffer (0.1-10mmol/L, pH≤6.0) DL-Homocysteine Target concentration: 0.0μmol/L, 30. 0 μmol/L Controls Low (optional) Liquid Phosphate buffer (0.1-10mmol/L, pH≤6.0) DL-Homocysteine Target concentration range: (8-20) μmol/L Controls High value (Optional) Liquid phosphate buffer (0.1-10mmol/L, pH≤6.0) DL-Homocysteine Target concentration range: (20-40)μmol/L The target value of the calibrator and the quality control range are batch specific, see the bottle label for details.
成分 浓度 试剂1 R1 NADH DL-丝氨酸 ≥0.1mmol/L ≥20mmol/L 试剂2 R2 胱硫醚-β-合成酶 胱硫醚-β-裂解酶 ≥2KU/L ≥2KU/L 校准品 (选配) 2水平，液体 磷酸盐缓冲液(0.1-10mmol/L，pH≤6.0） DL-同型半胱氨酸 目标浓度：0.0μmol/L、30.0μmol/L 质控品 低值 (选配) 液体 磷酸盐缓冲液(0.1-10mmol/L，pH≤6.0） DL-同型半胱氨酸 目标浓度范围：（8-20）μmol/L 质控品 高值 (选配) 液体 磷酸盐缓冲液(0.1-10mmol/L，pH≤6.0） DL-同型半胱氨酸 目标浓度范围：（20-40）μmol/L 校准品靶值、质控品质控范围具有批特异性，详见瓶签。
2 °C ~ 8 °C sealed and protected storage, the validity period is 12 months
2℃～8℃密封避光贮存，有效期为12个月
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Homocysteine (HCY) Determination Reagent Kit (Enzyme Cycling 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20222400291 and owned by Beijing Baiao Taikang Biotechnology Co., Ltd.. The device was approved on July 22, 2022.
This page provides complete registration details including registrant information, province location (Beijing), 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.