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禮亞尚單純皰疹病毒第一型/第二型免疫球蛋白G檢測試劑
🩺 醫材LIAISON HSV-1/2 IgG
衛署醫器輸字第020711號
醫材分類
第 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
#310800:HSV-1/2 IgG 100tests #310801:control HSV-1/2 IgG 2x2x1.3 mL
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適應症
禮亞尚單純皰疹病毒第一型/第二型免疫球蛋白G檢測試劑使用化學冷光免疫分析(CLIA)技術以定性測定人體血清或血漿檢體之單純皰疹病毒第一型/第二型(HSV-1/2)抗體。
醫材資訊
- 主成分
- Reagent:l. Magnetic particles (2.3mL): Magnetic particles coated with HSV recombinant protein, BSA, phosphate buffer, <0.l%sodium azide. 2.Calibrator l (2.5mL): Human serum/plasma containing low HSV IgG levels, BSA, phosphate buffer, preservatives, an inert yellow dye. 3. Calibrator 2 (2.5mL): Human serum/plasma containing High HSV IgG levels, BSA, phosphate buffer, preservatives, 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 1.3mL): Human serum/plasma stabilized in PBS buffer, non-reactive for HSV-1 IgG antibodies, BSA, preservatives. 2. Positive control (2 x 1.3mL): Human serum/plasma reavtive for HSV-1 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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