Coagulation Quality Control Product - NMPA Registration 粤械注准20242400158
Access comprehensive regulatory information for Coagulation Quality Control Product in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242400158 and owned by Rayto Life and Analytical Sciences Co., Ltd.. The device was approved on January 25, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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 suitable for quality control of prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB) and antithrombin III. (AT-III.) (optional). The TT item is only available for coagulation controls (Level 1).
本产品适用于凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）、纤维蛋白原（FIB）和抗凝血酶Ⅲ（AT-Ⅲ）（选配）项目的质量控制。其中TT项目只适用于凝血质控品（水平1）。
Made from sodium citrate anticoagulant human plasma blend.
由枸橼酸钠抗凝人血浆混合制成。
This product is stored at 2°C~8°C and has an expiration date of 24 months. After opening the bottle for reconstitution, the bottle mouth is closed and stored at 2°C~8°C with an expiration date of 8 hours, at room temperature (15°C~30°C) with an expiration date of 4 hours, and at -20±5°C with an expiration date of 2 weeks, and the quality control can only be frozen and thawed once.
本产品在2℃～8℃保存，有效期为24个月。 开瓶复溶后密闭瓶口，在2℃～8℃保存，有效期为8小时；在室温（15℃～30℃）保存，有效期为4小时；在-20±5℃保存，有效期为2周，质控品仅可冻融1次。