白介素6（IL-6）測定試劑盒（磁微?；瘜W(xué)發(fā)光法）

國產(chǎn) 有效注冊第二類

產(chǎn)品名稱：

注冊人名稱：

北京利德曼生化股份有限公司

注冊(備案)號：

京械注準20212400427

注冊人住所：

北京市北京經(jīng)濟技術(shù)開發(fā)區(qū)興海路5號

批準(備案)日期：

2021-08-09

有效期至：

2026-08-08

結(jié)構(gòu)及組成：

試劑盒由試劑1、試劑2、磁分離試劑、校準品和質(zhì)控品組成。tttttttttttttt組分ttttttttttttttt裝量ttttttttttttttt組成成分ttttttttttttttttttt50測試ttttttttttttttt100測試ttttttttttttttttttt試劑1（R1）ttttttttttttttt1.5 mL/瓶×1瓶ttttttttttttttt3.0 mL/瓶×1瓶ttttttttttttttt含有異硫氰酸熒光素（FITC）標記的抗IL-6抗體（濃度0.5 μg/mL）、牛血清白蛋白的磷酸鹽（PBS）緩沖液。ttttttttttttttttttt試劑2（R2）ttttttttttttttt1.5 mL/瓶×1瓶ttttttttttttttt3.0 mL/瓶×1瓶ttttttttttttttt含有堿性磷酸酶（ALP）標記的抗IL-6抗體（濃度1.5 μg/mL）、牛血清白蛋白的磷酸鹽（PBS）緩沖液。ttttttttttttttttttt磁分離試劑（M）ttttttttttttttt1.25 mL/瓶×1瓶ttttttttttttttt2.5 mL/瓶×1瓶ttttttttttttttt含有包被有FITC抗體的磁性微粒（濃度1.0 mg/mL）、牛血清白蛋白和疊氮鈉的三羥甲基氨基甲烷（Tris）緩沖液。ttttttttttttttttttt校準品（STD）ttttttttttttttt0.5 mL/瓶×6瓶ttttttttttttttt0.5 mL/瓶×6瓶ttttttttttttttt6個水平，由一定濃度的IL-6抗原和含牛血清白蛋白的緩沖液配制而成。6個校準品的目標濃度分別為0.00 pg/mL、15.00 pg/mL、50.00 pg/mL、200.00 pg/mL、1000.00 pg/mL和3000.00pg/mL。ttttttttttttttttttt質(zhì)控品（QC）ttttttttttttttt1.0 mL/瓶×2瓶ttttttttttttttt1.0 mL/瓶×2瓶ttttttttttttttt2個水平，由一定濃度的IL-6抗原和含牛血清白蛋白的緩沖液配制而成。2個質(zhì)控品的目標濃度分別為50.0pg/mL和1000.0pg/mL。tttttt 注：校準品和質(zhì)控品濃度具有批特異性，具體數(shù)值見瓶標簽。

適用范圍：

本產(chǎn)品用于體外定量測定人血清中的白介素6的含量。

變更情況：

t生產(chǎn)地址：“京械注準20212400427：北京市北京經(jīng)濟技術(shù)開發(fā)區(qū)興海路5號2層、6層、B1層”變更為“北京市北京經(jīng)濟技術(shù)開發(fā)區(qū)興海路 5 號 1 幢 2 層、6 層、B1 層、2 幢”。

(批準日期：20210813)

生產(chǎn)地址：

北京市北京經(jīng)濟技術(shù)開發(fā)區(qū)興海路5號2層、6層、B1層

型號規(guī)格：

100測試/盒t50測試/盒

產(chǎn)品儲存條件及有效期：

2℃~8℃保存，有效期為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
山東省醫(yī)用耗材限價掛網(wǎng)數(shù)據(jù)	白介素6（IL-6）測定試劑盒（磁微?；瘜W(xué)發(fā)光法）	京械注準20212400427	100測試/盒	2400.0000
湖南醫(yī)用耗材擬掛產(chǎn)品公示（第三十一批）	白介素6（IL-6）測定試劑盒（磁微?；瘜W(xué)發(fā)光法）	京械注準20212400427	100測試/盒	2400

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