1,5-Anhydro-D-Glucitol Assay Kit (Pyranose Oxidase Method)
- Device class
- Class II
- Model specifications
- Reagent 1 (R1): 60mLtimes; 2, Reagent 2 (R2): 20mLtimes; 2; Reagent 1 (R1): 60mLtimes; 1, Reagent 2 (R2): 20mLtimes; 1; Reagent 1 (R1): 45mLtimes; 1, Reagent 2 (R2): 15mLtimes; 1; Calibrator (optional): 1mLtimes; 1; Quality control (optional): level 1:1mLtimes; 1; Level 2: 1mLtimes; 1.试剂1（R1）：60mLtimes;2，试剂2（R2）：20mLtimes;2； 试剂1（R1）：60mLtimes;1，试剂2（R2）：20mLtimes;1； 试剂1（R1）：45mLtimes;1，试剂2（R2）：15mLtimes;1； 校准品（选配）：1mLtimes;1； 质控品(选配)：水平1：1mLtimes;1；水平2：1mLtimes;1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20162401142
- Approval date
- September 02, 2021
- Expiry date
- September 01, 2026
- Name
- Biosino BIO-TECHNOLOGY and Science INC.中生北控生物科技股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区超前路27号
- Production address
- 北京市昌平区科技园区超前路27号
For in vitro quantitative determination of 1,5-dehydrate-D-sorbitol (1,5-AG) content in human serum or plasma.
用于体外定量测定人血清或血浆中的1,5-脱水-D-山梨醇（1,5-AG）含量。
Reagent 1 (R1) (liquid) PYRUVATE KINASE (PK) 3KU/L Hexokinase (HK) 4KU/L Adenine nucleoside triphosphate (ATP) 1mmol/L 4-Aminoantipyrine (4-AAP) 1.5mmol/L Phosphoenolpyruvate (PEP) 4 mmol/L Ascorbate oxidase (AAO) 5KU/L Reagent 2 (R2) (liquid) PYRANOSE OXIDASE (PROD) 100KU/L HORSERADISH PEROXIDASE (HRP) 10KU/L Hydroxytosyliodobenzene (HTBI) 4.5mmol/L 3. Calibrator (liquid) Trimethylolaminomethane (Tris) buffer (100 mmol/L, pH 7.4), target concentration: 110 mu; mol/L. Each batch is valued, and the value has batch specificity, see the value list for details. 4. Controls (liquids) Trimethylolaminomethane (Tris) buffer (100 mmol/L, pH 7.4), level 2, concentration range of 1:20 mu, respectively; mol/L~70mu; mol/L, horizontal 2: 70mu; mol/L~150mu; mol/L. Each batch is valued, and the value has batch specificity, see the value list for details.
1. 试剂1（R1）（液体） 丙酮酸激酶（PK）3KU/L 己糖激酶（HK） 4KU/L 腺嘌呤核苷三磷酸（ATP） 1mmol/L 4-氨基安替比林（4-AAP） 1.5mmol/L 磷酸烯醇式丙酮酸(PEP)4 mmol /L 抗坏血酸氧化酶（AAO） 5KU/L 2. 试剂2（R2）（液体） 吡喃糖氧化酶(PROD) 100KU/L 辣根过氧化物酶(HRP) 10KU/L 羟基甲苯磺酰碘苯(HTBI) 4.5mmol/L 3. 校准品（液体） 三羟甲基氨基甲烷（Tris）缓冲液（100mmol/L，pH7.4），目标浓度：110mu;mol/L。每批定值，值有批特异性，详见值单。 4. 质控品（液体） 三羟甲基氨基甲烷（Tris）缓冲液（100mmol/L，pH7.4），2水平，浓度范围分别为水平1：20mu;mol/L~70mu;mol/L、水平2：70mu;mol/L~150mu;mol/L。每批定值，值有批特异性，详见值单。
2 °C ~ 8 °C stored in the dark, valid for 12 months.
2℃～8℃避光贮存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 1,5-Anhydro-D-Glucitol Assay Kit (Pyranose Oxidase 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20162401142 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on September 02, 2021.
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.