China NMPA legacy archive 京械注准20242400731Adiponectin assay kit (latex immunoturbidimetry)
- Device class
- Class II
- Model specifications
- 试剂1(R1):20mL;1,试剂2(R2):5mL;1;试剂1(R1):40mL;1,试剂2(R2):10mL;1;试剂1(R1):60mL;1,试剂2(R2):15mL;1;试剂1(R1):60mL;2,试剂2(R2):15mL;2;260测试/盒;280测试/盒;300测试/盒;450测试/盒;校准品:1mL;1;质控品:水平1:1mL;1;水平2:1mL;1.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400731
- Approval date
- November 26, 2024
- Expiry date
- November 25, 2029
- 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
用于体外定量测定人血清或血浆中脂联素(ADPN)的浓度.
用于体外定量测定人血清或血浆中脂联素（ADPN）的浓度。
1.试剂1(R1)甘氨酸缓冲液(pH7.0)100mmol/L2.试剂2(R2)包被脂联素抗体的胶乳颗粒0.2w/v%3.校准品(冻干粉)人血清基质(血清含量为50%),目标浓度范围为30.00mg/L～50.00mg/L,脂联素抗原来自基因工程菌表达.每批定值,值有批特异性,详见值单.4.质控品(冻干粉)人血清基质(血清含量为50%),两水平,浓度范围分别为水平1:2.00mg/L～7.00mg/L,水平2:8.00mg/L～25.00mg/L,脂联素抗原来自基因工程菌表达.每批定值,值有批特异性,详见值单.
1.试剂1（R1）甘氨酸缓冲液（pH7.0）100mmol/L2.试剂2（R2）包被脂联素抗体的胶乳颗粒0.2w/v%3.校准品（冻干粉）人血清基质（血清含量为50%），目标浓度范围为30.00mg/L～50.00mg/L，脂联素抗原来自基因工程菌表达。每批定值，值有批特异性，详见值单。4.质控品（冻干粉）人血清基质（血清含量为50%），两水平，浓度范围分别为水平1：2.00mg/L～7.00mg/L，水平2：8.00mg/L～25.00mg/L，脂联素抗原来自基因工程菌表达。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。
This static archive preserves historical registration fields and translations for Adiponectin assay kit (latex immunoturbidimetry), registration 京械注准20242400731. It does not establish current authorization or complete current product details.
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