Fibrinogen Soluble Determination Reagent Kit (Chromogenic Substrate Method) - NMPA Registration 浙械注准20242401608
Access comprehensive regulatory information for Fibrinogen Soluble Determination Reagent Kit (Chromogenic Substrate Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242401608 and owned by Ningbo Ruiyuan Biotechnology Co., Ltd.. The device was approved on July 15, 2024.
This page provides complete registration details including registrant information, province location (Zhejiang), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
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。