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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

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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