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禮亞尚單純皰疹病毒第一型/第二型免疫球蛋白M檢測試劑
🩺 醫材LIASION HSV-1/2 IgM
衛署醫器輸字第019986號
醫材分類
第 2 等級
- C.3305單純皰疹病毒血清分析
醫器規格
# 310820 1 KIT/100tests, # 310821 1 KIT/1.2 ml x 2 bot
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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M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一型與/或第二型(HSV-1與/或HSV-2)抗體於人體血清或血漿檢體。
醫材資訊
- 主成分
- Reagent:\n1.Magnetic particles 2.3mL:Magnetic particles coated with HSV viral lysate enriched with recombinant proteins, BSA, phosphate buffer, <0.1% sodium azide. 3.Calibrator 2 0.55mL:Human serum/plasma containing low HSV IgM levels, BSA, phosphate buffer, preservatives, an inert blue dye. 4.Buffer A 25mL:Coat IgG to human IgG (absorbent reagent), goat serum, BSA, phosphate buffer, preservatives, an inert blue dye. 5.Conjugate 23mL:Mouse monoclonal antibodies to human IgM conjugated to an isoluminol derivative, non-specific IgG (mouse polyclonal), BSA, phosphate buffer, preservatives. 2.Calibrator 1 0.55mL:Human serum/plasma containing low HSV IgM levels, BSA, phosphate buffer, preservatives, an inert yellow dye. Control:\n1.Negative control 1.2mL:Human serum/plasma without HSV IgM antibodies, stabilized in PBS buffer, BSA, preservatives. Controls are prediluted and therefore must not be used as specimens. 2.Positive control 1.2mL:Human serum/plasma containing HSV IgM antibodies, stabilized in PBS buffer, BSA, preservatives, an inert yellow dye. Controls are prediluted and therefore must not be used as specimens.
- 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
- 2029/04/10
- 發證日期
- 2009/04/10
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