China NMPA legacy archive 京械注准20242400772Homocysteine assay kit (enzyme cycle method)
- Device class
- Class II
- Model specifications
- 试剂1(R1):60mL;2,试剂2(R2):19mL;2,校准品:1mL;5(5个浓度);试剂1(R1):60mL;1,试剂2(R2):19mL;1,校准品:1mL;5(5个浓度);试剂1(R1):20mL;2,试剂2(R2):13mL;1,校准品:1mL;5(5个浓度);试剂1(R1):75mL;2,试剂2(R2):25mL;2,校准品:1mL;5(5个浓度);试剂1(R1):45mL;2,试剂2(R2):15mL;2,校准品:1mL;5(5个浓度);试剂1(R1):30mL;1,试剂2(R2):10mL;1,校准品:1mL;5(5个浓度).
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400772
- Approval date
- December 23, 2024
- Expiry date
- December 22, 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中同型半胱氨酸(Hcy)的浓度.
用于体外定量测定人血清中同型半胱氨酸（Hcy）的浓度。
1.试剂1(R1)乳酸脱氢酶10KU/L还原性辅酶Ⅰ(NADH)0.4mmol/L丝氨酸0.5mmol/L三(2-羧乙基)膦盐酸盐2mmol/L2.试剂2(R2)胱硫醚beta;-合成酶(CBS)2KU/L胱硫醚beta;-分解酶(CBL)2KU/L3.校准品人血清基质,5个浓度,浓度范围分别为浓度1:0.0mu;mol/L～4.0mu;mol/L、浓度2:5.0mu;mol/L～10.0mu;mol/L、浓度3:11.0mu;mol/L～20.0mu;mol/L、浓度4:21.0mu;mol/L～40.0mu;mol/L、浓度5:41.0mu;mol/L～60.0mu;mol/L.每批定值,值有批特异性,详见值单.
1.试剂1（R1）乳酸脱氢酶10KU/L还原性辅酶Ⅰ（NADH）0.4mmol/L丝氨酸0.5mmol/L三(2-羧乙基)膦盐酸盐2mmol/L2.试剂2（R2）胱硫醚beta;-合成酶（CBS）2KU/L胱硫醚beta;-分解酶（CBL）2KU/L3.校准品人血清基质，5个浓度，浓度范围分别为浓度1：0.0mu;mol/L～4.0mu;mol/L、浓度2：5.0mu;mol/L～10.0mu;mol/L、浓度3：11.0mu;mol/L～20.0mu;mol/L、浓度4：21.0mu;mol/L～40.0mu;mol/L、浓度5：41.0mu;mol/L～60.0mu;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。
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