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肌紅蛋白測定試劑盒（膠乳免疫比濁法）

國產(chǎn) 有效注冊第二類

產(chǎn)品名稱：

肌紅蛋白測定試劑盒（膠乳免疫比濁法）

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)20222400051

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)記肌紅蛋白抗體的膠乳溶液ttttttttttttttt0.2%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校準(zhǔn)品（選配）ttttttttttttttt人肌紅蛋白抗原tttttttttttttttS1 0.0ng/mL，tttttttttS2 80.0~120.0ng/mL，tttttttttS3 160.0~240.0ng/mL，tttttttttS4 320.0~480.0ng/mL，tttttttttS5 600.00~900.0ng/mL，ttttttttt濃度批特異，見靶值單tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt質(zhì)控品（選配）ttttttttttttttt人肌紅蛋白抗原tttttttttttttttQ1 80.0~150.0ng/mL，tttttttttQ2 200.0~400.0ng/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肌紅蛋白的含量。

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×5（5水平、凍干）ttttttttttttttttttt質(zhì)控品（選配）ttttttttttttttt0.5mL×2（2水平、凍干）

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

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