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胃蛋白酶原Ⅱ測(cè)定試劑盒（膠乳免疫比濁法）

國(guó)產(chǎn) 有效注冊(cè) 第二類

產(chǎn)品名稱：

胃蛋白酶原Ⅱ測(cè)定試劑盒（膠乳免疫比濁法）

注冊(cè)人名稱：

北京貝爾生物工程股份有限公司

注冊(cè)(備案)號(hào)：

京械注準(zhǔn)20222400049

注冊(cè)人住所：

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

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(jiàn)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(jiàn)靶值單tttttttttttttttttttProclin300ttttttttttttttt1mL/L

適用范圍：

本產(chǎn)品用于體外定量測(cè)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(kāi)發(fā)區(qū)創(chuàng)新路99號(hào)

型號(hào)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(chǔ)存條件及有效期：

試劑盒密封保存于2～8℃，有效期12個(gè)月

管理類別：

第二類

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