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禮亞尚單純皰疹病毒第二型免疫球蛋白G檢測試劑

🩺 醫材

LIAISON HSV-2 IgG

衛署醫器輸字第020712號

醫材分類

2 等級
  • A.1660品管材料(分析與非分析)
  • C.3305單純皰疹病毒血清分析

醫器規格

310810 (HSV-2 IgG) 1 KIT/100tests 310811 (control HSV-2 IgG) 1 KIT/2x0.7 mL

限制項目

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適應症

禮亞尚單純皰疹病毒第二型免疫球蛋白G檢測試劑使用化學冷光免疫分析(CLIA)技術以定性測定單純皰疹病毒第二型(HSV-2)抗體於人體血清或血漿檢體。

醫材資訊

主成分
Reagent:l. Magnetic particles 2.3mL: Magnetic particles coated with HSV-2 IgG Recombinant antigen, BSA, phosphate buffer, <0.l%sodium azide. 2.Calibrator l 1.8mL: Human serum/plasma containing low HSV-2 IgG levels, BSA, phosphate buffer, preservatvies, an inert yellow dye. 3. Calibrator 2 1.8mL : Human serum/plasma containing High HSV-2 IgG levels, BSA, phosphate buffer, preservatvies, an inert blue dye. 4. Buffer C 2.3mL: BSA, phosphate buffer, preservatives 5 .Specimen diluents 28mL: BSA, phosphate buffer, preservatives, an inert yellow dye. 6. Conjugate 23mL:Mouse monoclonal antibodies to human IgG conjugated to an isoluminol derivative, BSA, phosphate buffer, preservatives.\nControl: 1. Negative control 2 x 0.7mL: Human serum/plasma stabilized in PBS buffer, non-reactive for HSV-2 IgG antibodies, BSA, preservatives. 2. Positive control 2 x 0.7mL: Human serum/plasma reavtive for HSV-2 IgG antibodies, stabilized in PBS buffer, BSA, preservatives, an inert yellow dye.
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
2029/11/10
發證日期
2009/11/10

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