Anti-Müllerian Hormone Test Kit (Chemiluminescence Immunoassay Method) - NMPA Registration 苏械注准20242402176
Access comprehensive regulatory information for Anti-Müllerian Hormone Test Kit (Chemiluminescence Immunoassay 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 苏械注准20242402176 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on November 20, 2024.
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 the quantitative detection of anti-Mullerian hormone content in human serum in vitro.
用于体外定量检测人血清中抗缪勒氏管激素的含量。
试剂R1:含生物素标记的抗缪勒氏管激素单克隆抗体1(约1.0mg/L,鼠源性),pH约7.4三羟甲基氨基甲烷蛋白缓冲液(约0.05M),0.1% ProClin300;试剂R2:含吖啶酯标记的抗缪勒氏管激素单克隆抗体2(约0.7mg/L,鼠源性),pH约7.4三羟甲基氨基甲烷蛋白缓冲液(约0.05M),0.1% ProClin300;试剂M:含链霉亲和素包被的磁颗粒(约0.9mg/mL),0.01% MIT;校准品1:含抗缪勒氏管激素重组抗原(约0.2ng/mL,仓鼠卵巢细胞系),pH约7.4磷酸盐蛋白缓冲液(约0.1M),0.1% ProClin300,冻干品;校准品2:含抗缪勒氏管激素重组抗原(约8.0ng/mL,仓鼠卵巢细胞系),pH约7.4磷酸盐蛋白缓冲液(约0.1M),0.1% ProClin300,冻干品;校准品3:含抗缪勒氏管激素重组抗原(约0.5ng/mL,仓鼠卵巢细胞系),pH约7.4磷酸盐蛋白缓冲液(约0.1M),0.1% ProClin300,冻干品.试剂校准曲线可通过扫描标签二维码或射频识别(RFID)获得.
试剂R1：含生物素标记的抗缪勒氏管激素单克隆抗体1(约1.0mg/L,鼠源性)，pH约7.4三羟甲基氨基甲烷蛋白缓冲液（约0.05M），0.1% ProClin300；试剂R2：含吖啶酯标记的抗缪勒氏管激素单克隆抗体2(约0.7mg/L,鼠源性)，pH约7.4三羟甲基氨基甲烷蛋白缓冲液（约0.05M），0.1% ProClin300；试剂M：含链霉亲和素包被的磁颗粒(约0.9mg/mL)，0.01% MIT；校准品1：含抗缪勒氏管激素重组抗原(约0.2ng/mL，仓鼠卵巢细胞系)，pH约7.4磷酸盐蛋白缓冲液（约0.1M），0.1% ProClin300，冻干品；校准品2：含抗缪勒氏管激素重组抗原(约8.0ng/mL，仓鼠卵巢细胞系)，pH约7.4磷酸盐蛋白缓冲液（约0.1M），0.1% ProClin300，冻干品；校准品3：含抗缪勒氏管激素重组抗原(约0.5ng/mL，仓鼠卵巢细胞系)，pH约7.4磷酸盐蛋白缓冲液（约0.1M），0.1% ProClin300，冻干品。试剂校准曲线可通过扫描标签二维码或射频识别（RFID）获得。
2℃～8℃保存,有效期18个月;开封的试剂2℃～8℃保存,可稳定60天;复溶后的校准品在2℃～8℃可保存6小时,在-15℃可保存40天,反复冻融不超过3次.
2℃～8℃保存，有效期18个月；开封的试剂2℃～8℃保存，可稳定60天；复溶后的校准品在2℃～8℃可保存6小时，在-15℃可保存40天，反复冻融不超过3次。