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α1-微球蛋白測定試劑盒(膠乳免疫比濁法)

國產(chǎn) 有效 注冊 第二類
產(chǎn)品名稱:

α1-微球蛋白測定試劑盒(膠乳免疫比濁法)

注冊(備案)號:

滬械注準20212400228

注冊人住所:

上海市徐匯區(qū)欽州北路1189號

批準(備案)日期:

2021-04-13

有效期至:

2026-04-12

結(jié)構(gòu)及組成:

試劑1(R1):Good’s緩沖液;\\n試劑2(R2):Good’s緩沖液,包被了抗α1-微球蛋白的聚苯乙烯粒子;\\n校準品:緩沖液,α1-微球蛋白;\\n質(zhì)控品:緩沖液,α1-微球蛋白。(具體內(nèi)容詳見說明書)。

適用范圍:

供醫(yī)療機構(gòu)用于體外定量測定人血清、血漿或尿液樣本中α1-微球蛋白(α1-MG)濃度,作輔助診斷用。

變更情況:

1. 產(chǎn)品有效期,由9個月變更為18個月。\\n2. 產(chǎn)品技術(shù)要求文字性變更詳見附件1(共1頁)。\\n3. 產(chǎn)品說明書延長產(chǎn)品有效期、增加適用機型及文字性變更,詳見附件2(共1頁)。;本文件與“滬械注準20212400228”醫(yī)療器械注冊證共同使用。;2022-02-24,1、產(chǎn)品注冊證變更包裝規(guī)格,詳見附件1(共2頁)。\\n2、產(chǎn)品技術(shù)要求變更產(chǎn)品規(guī)格及其他文字性變更,詳見附件2(共4頁)。\\n3、產(chǎn)品說明書變更包裝規(guī)格、適用儀器及其他文字性變更,詳見附件3(共5頁)。;本文件與“滬械注準20212400228”注冊證共同使用。;2023-12-25

生產(chǎn)地址:

上海市徐匯區(qū)欽州北路1189號

型號規(guī)格:

規(guī)格1(189mL):R1:3×48mL,R2:3×15mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格2(108mL):R1:3×27mL,R2:3×9mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格3(153mL):R1:3×39mL,R2:3×12mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格4(102mL):R1:3×26mL,R2:3×8mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格5(260mL):R1:4×49mL,R2:4×16mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格6(188mL):R1:4×35mL,R2:4×12mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格7(36mL):R1:1×27mL,R2:1×9mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格8(1520T):R1:4×380T,R2:4×380T,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格9(1200T):R1:4×300T,R2:4×300T,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格10(600T):R1:4×150T,R2:4×150T,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL;\\n規(guī)格11(189mL):\\tR1:3×48mL,R2:3×15mL;\\n規(guī)格12(108mL):\\tR1:3×27mL,R2:3×9mL;\\n規(guī)格13(153mL):\\tR1:3×39mL,R2:3×12mL;\\n規(guī)格14(102mL):\\tR1:3×26mL,R2:3×8mL;\\n規(guī)格15(260mL):\\tR1:4×49mL,R2:4×16mL;\\n規(guī)格16(188mL):\\tR1:4×35mL,R2:4×12mL;\\n規(guī)格17(36mL):\\tR1:1×27mL,R2:1×9mL;\\n規(guī)格18(1520T):\\tR1:4×380T,R2:4×380T;\\n規(guī)格19(1200T):\\tR1:4×300T,R2:4×300T;\\n規(guī)格20(600T):\\tR1:4×150T,R2:4×150T;

產(chǎn)品儲存條件及有效期:

未開瓶的試劑、校準品、質(zhì)控品在2~8℃避光保存,有效期為9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
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格20(600T): R1:4×150T,R2:4×150T 9593.7000
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格8(1520T):R1:4×380T,R2:4×380T,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL 27040.8000
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格2(108mL):R1:3×27mL,R2:3×9mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL 5734.8000
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格2(108mL):R1:3×27mL,R2:3×9mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL 4587.8400
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格10(600T):R1:4×150T,R2:4×150T,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL 9593.7000
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格12(108mL):R1:3×27mL,R2:3×9mL 4587.2400
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格2:(108mL):R1:3×27mL,R2:3×9mL,校準品a:1×0.5mL,校準品b:1×0.5mL,校準品c:1×0.5mL,校準品d:1×0.5mL,校準品e:1×0.5mL,質(zhì)控品L:1×1.0mL,質(zhì)控品H:1×1.0mL; 5734.0500
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù) α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 規(guī)格?12:(108mL):R1:3×27mL,R2:3×9mL; 5734.0500
江西省+腎功和心肌酶生化試劑集采 α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 (36mL):R1:1×27mL,R2:1×9mL 267.4800
江西省+腎功和心肌酶生化試劑集采 α1-微球蛋白測定試劑盒(膠乳免疫比濁法) 滬械注準20212400228 (188mL):R1:4×35mL,R2:4×12mL 1396.8400
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