CA72-4 test kit (chemiluminescence method) - NMPA Registration 湘械注准20242400748
Access comprehensive regulatory information for CA72-4 test kit (chemiluminescence 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 湘械注准20242400748 and owned by Fosun Diagnostic Technology (Changsha) Co., Ltd. The device was approved on August 21, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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 in vitro quantitative detection of cancer antigen 72-4 (carbohydrate antigen 72-4, CA72-4) content in human serum or plasma. Clinically, it is used for the treatment and monitoring of malignant tumors such as the gastrointestinal system.
用于体外定量检测人血清或血浆中的癌抗原72-4（糖类抗原72-4，CA72-4）含量。临床上用于胃肠系统等恶性肿瘤的治疗监测。
R2:酶结合物试剂2,碱性磷酸酶标记的CA72-4单克隆抗体≥0.02µg/mL;R3:磁珠混悬液试剂3, CA72-4单克隆抗体包被的磁珠≥0.2mg/mL;CA72-4 CAL:癌抗原72-4校准品(可选配,独立包装),癌抗原72-4(天然抗原)[目标靶值范围:S0:0U/mL,S1:4-8U/mL,S2:150-200U/mL(浓度见定值表)]; CA72-4 CON:癌抗原72-4质控品(可选配,独立包装),癌抗原72-4(天然抗原)[目标靶值范围: C1:10-14U/mL,C2:50-80U/mL(浓度见定值表)].
R2:酶结合物试剂2,碱性磷酸酶标记的CA72-4单克隆抗体≥0.02µg/mL;R3:磁珠混悬液试剂3, CA72-4单克隆抗体包被的磁珠≥0.2mg/mL;CA72-4 CAL:癌抗原72-4校准品(可选配,独立包装),癌抗原72-4(天然抗原)[目标靶值范围:S0:0U/mL,S1:4-8U/mL,S2:150-200U/mL(浓度见定值表)];CA72-4 CON:癌抗原72-4质控品(可选配,独立包装),癌抗原72-4(天然抗原)[目标靶值范围: C1:10-14U/mL,C2:50-80U/mL(浓度见定值表)]。
1. Store under 2~8°C, protect from light, and seal the storage conditions, and the kit is valid for 12 months. 2. After the reagent is enabled, it can be stable for 30 days when placed on the analyzer. 3. The calibrators and quality controls should be sealed after opening and stored at 18~25°C under the condition of avoiding light, which can be stable for 24 hours; It can be stored at 2~8 °C and can be stable for 30 days.
1.在2～8℃、避光、密封的储存条件下保存，试剂盒有效期为12个月。2.试剂启用后，置于分析仪上可稳定30天。3.校准品、质控品开封后应密封，在18～25℃避光的条件下贮存，可稳定24小时；在2～8℃避光的条件下贮存，可稳定30天。