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促腎上腺皮質(zhì)激素(ACTH)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:

促腎上腺皮質(zhì)激素(ACTH)測定試劑盒(磁微?;瘜W(xué)發(fā)光法)

注冊(備案)號:

京械注準20212400421

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)ttttttttttttttt2.5 mL/瓶×1瓶ttttttttttttttt5.0 mL/瓶×1瓶ttttttttttttttt含有異硫氰酸熒光素(FITC)標記的抗ACTH抗體(濃度0.6 µg/mL)、牛血清白蛋白和疊氮鈉的磷酸鹽(PBS)緩沖液。ttttttttttttttttttt試劑2(R2)ttttttttttttttt2.5 mL/瓶×1瓶ttttttttttttttt5.0 mL/瓶×1瓶ttttttttttttttt含有堿性磷酸酶(ALP)標記的抗ACTH抗體(濃度0.5 µg/mL)、牛血清白蛋白和疊氮鈉的磷酸鹽(PBS)緩沖液。ttttttttttttttttttt磁分離試劑(M)ttttttttttttttt2.5mL/瓶×1瓶ttttttttttttttt5.0 mL/瓶×1瓶ttttttttttttttt含有包被有抗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個水平凍干品,由一定濃度ACTH抗原和含牛血清白蛋白的Tris緩沖液配制而成。校準品的目標濃度分別為0 pg/mL,50.00 pg/mL, 200.00 pg/mL,500.00 pg/mL,1000.00 pg/mL和2000.00 pg/mL。ttttttttttttttttttt質(zhì)控品(QC)ttttttttttttttt1.0 mL/瓶×2瓶ttttttttttttttt1.0 mL/瓶×2瓶ttttttttttttttt2個水平凍干品,由一定濃度ACTH抗原和含牛血清白蛋白的Tris緩沖液配制而成。質(zhì)控的目標濃度為50.00pg/mL和500.00 pg/mL。tttttt tt 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漿樣本中促腎上腺皮質(zhì)激素的含量。

變更情況:

t生產(chǎn)地址:“京械注準20212400421: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) 促腎上腺皮質(zhì)激素(ACTH)測定試劑盒(磁微?;瘜W(xué)發(fā)光法) 京械注準20212400421 100測試/盒 3500.0000