α1-微球蛋白測(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：

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)20212400228

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：

2021-05-10

有效期至：

2026-05-09

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α1-微球蛋白多抗的膠乳溶液ttttttttttttttt0.3%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校準(zhǔn)品（選配）ttttttttttttttt人α1-微球蛋白抗原tttttttttttttttS1 0.00mg/L，tttttttttS2 8.00~15.00mg/L，tttttttttS3 20.00~30.00mg/L，tttttttttS4 40.00~60.00mg/L，tttttttttS5 80.00~120.00mg/L，tttttttttS6 150.00~200.00mg/Lttttttttt濃度批特異，見(jiàn)靶值單tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt質(zhì)控品（選配）ttttttttttttttt人α1-微球蛋白抗原tttttttttttttttQ1 10.00~30.00mg/L，tttttttttQ2 40.00~80.00mg/L，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、血漿和尿液樣本中α1-微球蛋白的含量。

生產(chǎn)地址：

北京市大興區(qū)黃村鎮(zhèn)蘆城工業(yè)開(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

掛網(wǎng)信息

數(shù)據(jù)來(lái)源	注冊(cè)備案名	注冊(cè)證編號(hào)	型號(hào)規(guī)格	掛網(wǎng)報(bào)價(jià)
湖南醫(yī)用耗材擬掛產(chǎn)品公示（第五十三批）	a1-微球蛋白測(cè)定試劑盒（膠乳免疫比濁法）	京械注準(zhǔn)20212400228	R1 45ml2,R2 15ml2	12000

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