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China NMPA legacy archive 京械注准20162401142

1,5-Anhydro-D-Glucitol Assay Kit (Pyranose Oxidase Method)

1,5-脱水-D-山梨醇测定试剂盒(吡喃糖氧化酶法)
Biosino BIO-TECHNOLOGY and Science INC.Class IINMPAApproved September 02, 2021
Static archiveNMPA · legacy registration snapshot
Device classification
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 information
Registration number
京械注准20162401142
Approval date
September 02, 2021
Expiry date
September 01, 2026
Registrant
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 facility
Production address
北京市昌平区科技园区超前路27号
Intended use
English

For in vitro quantitative determination of 1,5-dehydrate-D-sorbitol (1,5-AG) content in human serum or plasma.

中文

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。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

2 °C ~ 8 °C stored in the dark, valid for 12 months.

中文

2℃~8℃避光贮存,有效期12个月。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for 1,5-Anhydro-D-Glucitol Assay Kit (Pyranose Oxidase Method), registration 京械注准20162401142. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.