Homocysteine (HCY) Determination Reagent Kit (Enzyme Cycling Method) - NMPA Registration 京械注准20222400291

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.

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NMPA Official Data

Class II

京械注准20222400291

Homocysteine (HCY) Determination Reagent Kit (Enzyme Cycling Method)

同型半胱氨酸（HCY）测定试剂盒（酶循环法）

NMPA Registration Number: 京械注准20222400291

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Intended Use

English

For in vitro quantitative detection of homocysteine concentrations in human serum.

中文

用于体外定量检测人血清中同型半胱氨酸的浓度。

Device Classification

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 Information

Registration Number

京械注准20222400291

Approval Date

July 22, 2022

Expiry Date

July 21, 2027

Registrant

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 Facility

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）

Structure and Composition

English

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.

中文

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。

Storage Conditions and Expiration

English

2 °C ~ 8 °C sealed and protected storage, the validity period is 12 months

中文

2℃～8℃密封避光贮存，有效期为12个月

Additional Information

Appendix

产品技术要求