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.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20162401142
- Approval date
- September 02, 2021
- Expiry date
- September 01, 2026
- Province/Region
- Beijing
- Address
- No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing
- 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
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