China NMPA legacy archive 浙械注准20242401608Fibrinogen Soluble Determination Reagent Kit (Chromogenic Substrate Method)
- Device class
- Class II
- Model specifications
- 试剂1:1×3mL、试剂2:1×3mL;试剂1:2×5mL、试剂2:2×5mL;试剂1:3×5mL、试剂2:3×5mL;试剂1:5×5mL、试剂2:5×5mL;凝血校准品(可选购):1×1mL;凝血质控品低值(可选购):1×1mL;凝血质控品高值(可选购):1×1mL.
- Approval department
- Zhejiang Provincial Drug Administration
- Registration number
- 浙械注准20242401608
- Approval date
- July 15, 2024
- Expiry date
- July 14, 2029
- Province/Region
- Zhejiang
- Address
- No. 288, Huangjipu Road, Jiangbei District, Ningbo City
- Production address
- 宁波市江北区皇吉浦路288号
This product is used for in vitro determination of plasminogen activity in human plasma.
本产品用于体外测定人血浆中纤维蛋白溶酶原的活性。
Reagent 1: streptokinase; Reagent 2: pyroGlu-Phe-Lys-pNA•HCl (pyroglutamic acid-phenylalanine-lysine-p-nitroaniline · hydrochloride); Coagulation calibrator: lyophilized with plasminogen; Coagulation controls: lyophilized products containing plasminogen. (Please refer to the manual for details)
试剂1：链激酶；试剂2：pyroGlu-Phe-Lys-pNA•HCl （焦谷氨酸-苯丙氨酸-赖氨酸-p-硝基苯胺·盐酸盐）；凝血校准品：含纤溶酶原的冻干品；凝血质控品：含纤溶酶原的冻干品。（具体内容详见说明书）
The kit can be stored at 2~8°C and can be stable for 12 months when stored in the dark.
试剂盒贮存在2～8℃下，避光保存可稳定12个月。
- Appendix
- 产品技术要求、说明书
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