胃蛋白酶原Ⅱ測定試劑盒（膠乳免疫比濁法）

國產(chǎn) 有效注冊第二類

產(chǎn)品名稱：

注冊人名稱：

北京貝爾生物工程股份有限公司

注冊(備案)號：

京械注準(zhǔn)20222400049

注冊人住所：

北京市大興區(qū)黃村鎮(zhèn)蘆城工業(yè)開發(fā)區(qū)創(chuàng)新路99號

批準(zhǔn)(備案)日期：

2022-01-17

有效期至：

2027-01-16

結(jié)構(gòu)及組成：

類型ttttttttttttttt主要成分ttttttttttttttt濃度ttttttttttttttttttt試劑1（R1）tttttttttttttttPBS緩沖液ttttttttttttttt50mMtttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt試劑2（R2）ttttttttttttttt標(biāo)記胃蛋白酶原Ⅱ抗體的膠乳溶液ttttttttttttttt0.2%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校準(zhǔn)品(選配)ttttttttttttttt人胃蛋白酶原Ⅱ抗原tttttttttttttttS1 0.00ng/mL，tttttttttS2 3.00~8.00ng/mL，tttttttttS3 9.00~18.00ng/mL，tttttttttS4 20.00~30.0ng/mL，tttttttttS5 40.00~60.0ng/mL，tttttttttS6 80.00~120.0ng/mL，ttttttttt濃度批特異，見靶值單tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt質(zhì)控品（選配）ttttttttttttttt人胃蛋白酶原Ⅱ抗原tttttttttttttttQ1 8.00~20.00ng/mL，tttttttttQ2 25.00~50.00ng/mL，ttttttttt濃度批特異，見靶值單tttttttttttttttttttProclin300ttttttttttttttt1mL/L

適用范圍：

本產(chǎn)品用于體外定量測定人血清和血漿樣本中胃蛋白酶原Ⅱ的含量。

生產(chǎn)地址：

北京市大興區(qū)黃村鎮(zhèn)蘆城工業(yè)開發(fā)區(qū)創(chuàng)新路99號

型號規(guī)格：

組分ttttttttttttttt規(guī)格ttttttttttttttttttt試劑tttttttttttttttR1 45mL×2/R2 15mL×2tttttttttttttttttttR1 45mL×1/R2 15mL×1tttttttttttttttttttR1 22.5mL×1/R2 7.5mL×1tttttttttttttttttttR1 7.5mL×1/R2 2.5mL×1ttttttttttttttttttt校準(zhǔn)品(選配)ttttttttttttttt0.5mL×6ttttttttttttttttttt質(zhì)控品(選配)ttttttttttttttt0.5mL×2

產(chǎn)品儲存條件及有效期：

試劑盒密封保存于2～8℃，有效期12個月

管理類別：

第二類

掛網(wǎng)信息

數(shù)據(jù)來源	注冊備案名	注冊證編號	型號規(guī)格	掛網(wǎng)報價
湖南醫(yī)用耗材擬掛產(chǎn)品公示（第五十三批）	胃蛋白酶原Ⅱ測定試劑盒（膠乳免疫比濁法）	京械注準(zhǔn)20222400049	R1 45ml2,R2 15ml2	12000

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