"Ximenzi" Hepatitis B e Anti-體檢驗試劑組 - Taiwan Registration 6eead68bf19839a71434b7fff200e680
Access comprehensive regulatory information for "Ximenzi" Hepatitis B e Anti-體檢驗試劑組 in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 6eead68bf19839a71434b7fff200e680 and manufactured by BIOKIT S.A.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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Device Details
Registration Details
6eead68bf19839a71434b7fff200e680
DHA05603751500
Product Details
This product is used for in vitro diagnostics and can be used with the Atellica IM analyzer to qualitatively detect antibodies to HBV e antigen in human (over 2 years old) serum, EDTA plasma or lithium heparin plasma in patients with signs or symptoms of hepatitis B infection, or who are at risk of hepatitis B virus (HBV) infection, or who are known to be infected with HBV. Test results, along with other diagnostic information, can be used to assist in determining the clinical status of HBV or in the management of HBV disease.
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); B.4020 Analysis of specific tests
委託製造;; QMS/QSD;; 輸入
Dates and Status
Nov 19, 2024
Nov 19, 2029