Coagulation multiple quality control product - NMPA Registration 苏械注准20232400867
Access comprehensive regulatory information for Coagulation multiple 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 苏械注准20232400867 and owned by Ali Biotech Taizhou Co., Ltd.. The device was approved on June 19, 2023.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
It is used for quality control during prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), and antithrombin III (AT III) detection.
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）、抗凝血酶III（AT III）检测时的质量控制。
This product is a lyophilized product, composed of sodium citrate anticoagulant plasma (bovine, pig), buffer stabilizer; Level 1 is a normal value control and level 2 is an abnormal value control product. Level 1 target range: prothrombin time (PT): 8~14s, activated partial thromboplastin time (APTT): 21~35s, thrombin time (TT): 10~20s, fibrinogen (FIB): 2~4g/L, antithrombin III (AT III): 80~120% Level 2 Target range: prothrombin time (PT): 18~48s, activated partial thromboplastin time (APTT): 45~75s, Thrombin time (TT): 21~40s, fibrinogen (FIB): 0.7~1.9g/L, antithrombin III(AT III): 30~50%
本产品为冻干品，由枸橼酸钠抗凝血浆（牛、猪）、缓冲稳定剂组成；水平1为正常值质控品，水平2为异常值质控品。水平1靶值范围：凝血酶原时间（PT）：8~14s、活化部分凝血活酶时间（APTT）：21~35s、凝血酶时间（TT）：10~20s、纤维蛋白原（FIB）：2~4g/L、抗凝血酶III（AT III）：80~120%水平2靶值范围：凝血酶原时间（PT）：18~48s、活化部分凝血活酶时间（APTT）：45~75s、凝血酶时间（TT）：21~40s、纤维蛋白原（FIB）：0.7~1.9g/L、抗凝血酶III（AT III）：30~50%
1. The quality control products are not opened and stored in the dark at 2 °C ~ 8 °C, and the validity period is 24 months; After reconstitution, store at 2 °C ~ 8 °C in the dark, the validity period is 6 hours. 2. Please refer to the product label for the production date and expiration date.
1.质控品未拆封在2℃～8℃避光保存，有效期为24个月；复溶后在2℃～8℃避光保存，有效期为6小时。2.生产日期、失效日期详见产品标签。