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禮亞尚抗細胞核萃取物抗體檢測試劑

🩺 醫材

LIAISON ENA Screen

衛署醫器輸字第021941號

醫材分類

2 等級
  • C.5100抗核抗體免疫試驗系統

醫器規格

#310330 100tests/kit;#310331 0.9mL x 4 vial/kit,以下空白

限制項目

輸 入

適應症

禮亞尚抗細胞核萃取物抗體檢測試劑使用化學冷光免疫分析(CLIA)技術,定性測定人類血清或血漿樣本中,以下各項可抽取式人類核抗原(ENA)自體抗體:RNP/Sm, SS-A (Ro), SS-B (La), Scl-70, Jo-1和著絲點(CENP-B)。必須使用禮亞尚分析儀進行檢測分析。

醫材資訊

主成分
Reagent integral-1.Magnetic particles 2.3mL : Magnetic particles coated with highly purified and recombinant antigens[SS-A (Ro),SS-B(La),RNP/Sm, Scl-70, Jo-1 and CENP-B], BSA, phosphate buffer, <0.1% sodium azide.2. Calibrator 1 2.1mL: Human serum/plasma containing low anti-extractable nuclear IgG levels, BSA, phosphate buffer, preservatives, an inert yellow dye. The calibrator concentrations are referenced to an in-house antibody preparation. 3. Calibrator 2 2.1mL: Human serum/plasma containing low anti-extractable nuclear IgG levels, BSA, phosphate buffer, preservatives, an inert blue dye. The calibrator concentrations are referenced to an in-house antibody preparation.4.specimen diluents 28mL: BSA, phosphate buffer, preservatives, an inert yellow dye.5.conjugate 23mL: Mouse monoclonal antibodies to human IgG conjugated to an isoluminol derivative, BSA, phosphate buffer, preservatives.\n6.Negative Control 2 x0.9mL:Human serum/plasma non-reactive for anti-extractable nuclear(ENA) IgG antibodies, stabilized i
製造商
DIASORIN ITALIA S.P.A.
製造國
IT
申請商
太暘生物科技股份有限公司
有效日期
2026/02/11
發證日期
2011/02/11

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