"恩奈格斯特" 帶狀泡疹病毒 IgM抗體 檢驗試劑組

醫療器材許可證 · 許可證字號：衛署醫器輸字第013315號

許可證字號

衛署醫器輸字第013315號

註銷狀態

已註銷

註銷日期

2021/03/04

註銷理由

未展延而逾期者

有效日期

2020/10/27

發證日期

2005/10/27

許可證種類

09

醫療器材級數

2

通關簽審文件編號

DHA00601331506

中文品名

"恩奈格斯特" 帶狀泡疹病毒 IgM抗體 檢驗試劑組

英文品名

"Enzygnost" Enzygnost Anti-VZV/IgM

效能

定性檢測和定量測定人類血清和血漿中帶狀泡疹病毒特異性IgM抗體的酵素免疫分析法。

醫器主類別一

C 免疫學及微生物學

主成分略述

Enzygnost* Anti-VZV/igM Test Plate: microtitration plate coated with inactivated VZV-antigens The left row of a strip contains antigen from VZV infected human fibroblasts and the right row contains antigen from uninfecte…展開

Enzygnost* Anti-VZV/igM Test Plate: microtitration plate coated with inactivated VZV-antigens The left row of a strip contains antigen from VZV infected human fibroblasts and the right row contains antigen from uninfected cells (=control antigen). \nAnti-Human-IgM/POD Conjugate: Goat antibodies to human IgM conjugated with peroxidase in 0.05 mo/L Tris/HCl Buffer solution, pH 7.2, with polygeline 0.5%.\nConjugate Buffer Microbiol: 37 mg EDTA in one liter of 0.01 mol/L phosphate buffer solution, pH 7.2, with Tetronic, approximately 2%, BSA approximately 1%. \nAnti-VZV Reference P/P: Human serum with IgG-antibodies to VZV-antigens in conjunction with rheumatoid factors (RF) in Tris buffer solution (20 mmol/L), pH 7.4, with HUmanalbin (5%), approximately 60%. \nAnti-VZV Reference P/N: Human serum with IgG-antibodies to VZV-antigens in Tris buffer solution (20 mmol/L), pH 7.4, with Humanalbin (5%), approximately 60%. \nSample Buffer POD 0.3 mol/L Tris/HCl buffer solution, pH 8.0-8.2, with Tween 20 approximately 0.收合

醫器規格

#|OWL 15: 2×48 Test/kit

限制項目

輸 入

申請商名稱

西門子醫療設備股份有限公司

申請商地址

臺北市南港區園區街3號2樓之2

申請商統一編號

24843993

製造商名稱

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

製造廠廠址

EMIL-VON-BEHRING-STR. 76, D-35041 MARBURG, GERMANY

製造廠國別

DE

異動日期

2021/03/06

製造許可登錄編號

QSD5584

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