Homocysteine assay kit (enzyme cycle method)
- Device class
- Class II
- Model specifications
- Reagent 1: 1×36ml/bottle Reagent 2: 1×10ml Reagent 1: 2×36ml/bottle Reagent 2: 2×10ml Reagent 1: 4×36ml/bottle Reagent 2: 2×20ml Reagent 1:4×63ml/bottle Reagent 2: 2×35ml Calibrator: 2×0.5ml 2×1ml Control: Level 1: 1×0.5ml 1×1ml Horizontal 2: 1×0.5ml 1× 1ml试剂1：1×36ml/瓶 试剂2：1×10ml 试剂1：2×36ml/瓶 试剂2：2×10ml 试剂1：4×36ml/瓶 试剂2：2×20ml 试剂1：4×63ml/瓶 试剂2：2×35ml 校准品：2×0.5ml 2×1ml质控品：水平1:1×0.5ml 1×1ml 水平2:1×0.5ml 1× 1ml
- Approval department
- Hebei Food and Drug Administration河北省食品药品监督管理局
- Registration number
- 冀械注准20212400268
- Approval date
- May 08, 2021
- Expiry date
- May 07, 2026
- Name
- Langfang Hengyi Biotechnology Co., Ltd.廊坊恒益生物技术有限公司
- Province/Region
- Hebei河北
- Address
- No. 1, Yilan Road, Yongqing Taiwan New Industrial City, Langfang City, Hebei Province河北省廊坊市永清台湾工业新城宜兰道1号
- Production address
- 廊坊永清台湾工业新城宜兰道1号
It is used for the quantitative determination of homocysteine content in human serum or plasma in vitro.
用于体外定量测定人血清或血浆中同型半胱氨酸的含量。
Reagent 1: serine, 0.1mmol/L; reduced β-nicotinamide adenine dinucleotide (NADH), 0.20mmol/L; Tris(2 carboxyethyl)phosphine (TCEP), 0.5mmol/L; а-Ketoglutaric acid, 5.0 mmol/L; Reagent 2: cystathionine lyase CBL, 10KU/L; Cystathionine synthetase CBS 2KU/L. Calibrator: homocysteine; Trimethylolaminomethane. Controls: homocysteine; Trimethylolaminomethane.
试剂1：丝氨酸，0.1mmol/L；还原型β-烟酰胺腺嘌呤二核苷酸（NADH），0.20mmol/L;三（2羧乙基）膦（TCEP），0.5mmol/L；а-酮戊二酸，5.0mmol/L； 试剂2：胱硫醚裂解酶CBL，10KU/L；胱硫醚合成酶CBS 2KU/L。 校准品：同型半胱氨酸；三羟甲基氨基甲烷。 质控品：同型半胱氨酸；三羟甲基氨基甲烷。
Access comprehensive regulatory information for Homocysteine assay kit (enzyme cycle 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 冀械注准20212400268 and owned by Langfang Hengyi Biotechnology Co., Ltd.. The device was approved on May 08, 2021.
This page provides complete registration details including registrant information, province location (Hebei), 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.