肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法) - NMPA Registration 沪械注准20242400393
Access comprehensive regulatory information for 肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 沪械注准20242400393 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on November 14, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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.
本试剂盒供医疗机构用于体外定量测定人体血清或血浆样本中肌酸激酶同工酶的含量,临床上用于心肌梗死、肌病等疾病的辅助诊断.
本试剂盒供医疗机构用于体外定量测定人体血清或血浆样本中肌酸激酶同工酶的含量，临床上用于心肌梗死、肌病等疾病的辅助诊断。
试剂1(R1):Good's缓冲液;试剂2(R2):Good's缓冲液、包被了CKMB单抗抗体的聚苯乙烯粒子;校准品a-f:Good's缓冲液、CKMB重组蛋白、正常人血清或血浆;质控品L、H:Good's缓冲液、CKMB重组蛋白、正常人血清或血浆.
试剂1（R1）：Good’s缓冲液；试剂2（R2）：Good’s缓冲液、包被了CKMB单抗抗体的聚苯乙烯粒子；校准品a-f：Good’s缓冲液、CKMB重组蛋白、正常人血清或血浆；质控品L、H：Good’s缓冲液、CKMB重组蛋白、正常人血清或血浆。
2 °C ~ 8 °C protected from light, valid for 12 months.
2℃～8℃避光保存，有效期12个月。