Carcinoembryonic Antigen 15-3 Test Kit (Chemiluminescence Method) - NMPA Registration 湘械注准20242401134
Access comprehensive regulatory information for Carcinoembryonic Antigen 15-3 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20242401134 and owned by Fosun Diagnostic Technology (Changsha) Co., Ltd. The device was approved on November 13, 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.
供医疗机构用于对人体血清样本或血浆样本中癌抗原15-3含量的体外定量检测.临床上用于乳腺癌的治疗监测.
供医疗机构用于对人体血清样本或血浆样本中癌抗原15-3含量的体外定量检测。临床上用于乳腺癌的治疗监测。
R2:酶结合物试剂2,碱性磷酸酶标记的癌抗原15-3单克隆抗体≥0.4ug/mL,PBS缓冲液10mmol/L;R3:磁珠混悬液试剂3,磁珠包被的癌抗原15-3单克隆抗体≥0.2mg/mL,PBS缓冲液10mmol/L;CA15-3 CAL:癌抗原15-3校准品(可选配,独立包装),癌抗原15-3(天然抗原)[浓度范围:S0:0 U/mL,S1:10-20U/mL,S2:50-100U/mL (浓度见定值表)];CA15-3 CON:癌抗原15-3质控品(可选配,独立包装),癌抗原15-3(天然抗原)[浓度范围:C1:10-40U/mL,C2:60-120U/mL(浓度见定值表)].
R2：酶结合物试剂2,碱性磷酸酶标记的癌抗原15-3单克隆抗体≥0.4ug/mL，PBS缓冲液10mmol/L；R3:磁珠混悬液试剂3,磁珠包被的癌抗原15-3单克隆抗体≥0.2mg/mL，PBS缓冲液10mmol/L；CA15-3 CAL:癌抗原15-3校准品(可选配，独立包装)，癌抗原15-3(天然抗原)[浓度范围：S0:0 U/mL，S1：10-20U/mL，S2：50-100U/mL (浓度见定值表)]；CA15-3 CON:癌抗原15-3质控品(可选配,独立包装),癌抗原15-3(天然抗原)[浓度范围：C1：10-40U/mL,C2:60-120U/mL(浓度见定值表)]。
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,置于分析仪冷藏槽中可稳定30天.3.校准品、质控品开瓶后,在18～25℃避光的条件下贮存,可稳定6小时;在2～8℃避光的条件下贮存,可稳定30天.4.生产日期、失效日期见试剂盒标签.
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，置于分析仪冷藏槽中可稳定30天。3.校准品、质控品开瓶后，在18～25℃避光的条件下贮存，可稳定6小时；在2～8℃避光的条件下贮存，可稳定30天。4.生产日期、失效日期见试剂盒标签。