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

醫療器材許可證 · 許可證字號：衛署醫器輸字第019986號

許可證字號

衛署醫器輸字第019986號

有效日期

2029/04/10

發證日期

2009/04/10

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601998605

中文品名

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

英文品名

LIASION HSV-1/2 IgM

效能

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。

醫器主類別一

C 免疫學及微生物學

醫器次類別一

C.3305 單純皰疹病毒血清分析

主成分略述

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 …展開

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.收合

醫器規格

# 310820 1 KIT/100tests, # 310821 1 KIT/1.2 ml x 2 bot

限制項目

輸 入

申請商名稱

太暘生物科技股份有限公司

申請商地址

新北市汐止區福德三路369號12樓

申請商統一編號

20921362

製造商名稱

DIASORIN ITALIA S.P.A.

製造廠廠址

VIA CRESCENTINO SNC, 13040 SALUGGIA (VC), ITALY

製造廠國別

IT

異動日期

2024/01/11

製造許可登錄編號

QSD3311

建立時間 2026-09-22 15:59:33 · 更新時間 2026-09-22 15:59:33