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胃蛋白酶原Ⅱ(PGⅡ)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:

胃蛋白酶原Ⅱ(PGⅡ)測定試劑盒(磁微粒化學(xué)發(fā)光法)

注冊(備案)號(hào):

京械注準(zhǔn)20212400422

注冊人住所:

北京市北京經(jīng)濟(jì)技術(shù)開發(fā)區(qū)興海路5號(hào)

批準(zhǔn)(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(zhǔn)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(biāo)記的PGⅡ抗體(濃度1.0 µg/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(biāo)記的抗PGⅡ抗體(濃度0.5µg/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磁分離試劑(M)ttttttttttttttt2.5mL/瓶×1瓶ttttttttttttttt5.0 mL/瓶×1瓶ttttttttttttttt含包被有抗異硫氰酸熒光素(FITC)抗體的磁性微粒(濃度1.0mg/mL)、牛血清白蛋白和疊氮鈉的三羥基甲基氨基甲烷(Tris)緩沖液。ttttttttttttttttttt校準(zhǔn)品(STD)ttttttttttttttt0.5 mL/瓶×6瓶ttttttttttttttt0.5 mL/瓶×6瓶ttttttttttttttt6個(gè)水平凍干品,由一定濃度PGⅡ抗原和含牛血清白蛋白的緩沖液配制而成。校準(zhǔn)品的目標(biāo)濃度分別為0.00 ng/mL,5.00 ng/mL,10.00 ng/mL,25.00 ng/mL,50.00 ng/mL和100.00 ng/mL。ttttttttttttttttttt質(zhì)控品(QC)ttttttttttttttt1.0 mL/瓶×2瓶ttttttttttttttt1.0 mL/瓶×2瓶ttttttttttttttt2個(gè)水平凍干品,由一定濃度PGⅡ抗原和含牛血清白蛋白的緩沖液配制而成。質(zhì)控品的目標(biāo)濃度為10.00ng/mL和50.00ng/mL。tttttt t注:校準(zhǔn)品及質(zhì)控品濃度具有批特異性,具體數(shù)值見瓶標(biāo)簽。

適用范圍:

本產(chǎn)品用于體外定量測定人血清樣本中的胃蛋白酶原Ⅱ(PGⅡ)含量。

變更情況:

t生產(chǎn)地址:“京械注準(zhǔn)20212400422:北京市北京經(jīng)濟(jì)技術(shù)開發(fā)區(qū)興海路5號(hào)2層、6層、B1層”變更為“北京市北京經(jīng)濟(jì)技術(shù)開發(fā)區(qū)興海路 5 號(hào) 1 幢 2 層、6 層、B1 層、2 幢”。

(批準(zhǔn)日期:20210813)

生產(chǎn)地址:

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

型號(hào)規(guī)格:

100測試/盒;50測試/盒

產(chǎn)品儲(chǔ)存條件及有效期:

2℃~8℃保存,有效期為12個(gè)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(hào) 型號(hào)規(guī)格 掛網(wǎng)報(bào)價(jià)
山東省醫(yī)用耗材限價(jià)掛網(wǎng)數(shù)據(jù) 胃蛋白酶原Ⅱ(PGⅡ)測定試劑盒(磁微粒化學(xué)發(fā)光法) 京械注準(zhǔn)20212400422 100測試/盒 3800.0000