China NMPA legacy archive 沪械注准20242400393肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法)
- Device class
- Class II
- Approval department
- Shanghai Municipal Drug Administration
- Registration number
- 沪械注准20242400393
- Approval date
- November 14, 2024
- Expiry date
- November 13, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区钦州北路1189号
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。
This static archive preserves historical registration fields and translations for 肌酸激酶同工酶测定试剂盒(胶乳免疫比浊法), registration 沪械注准20242400393. It does not establish current authorization or complete current product details.
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