"Siemens" hepatitis B surface antigen quantification kit - Taiwan Registration e6325554565d202973cb7e97c8f5bcf3
Access comprehensive regulatory information for "Siemens" hepatitis B surface antigen quantification kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e6325554565d202973cb7e97c8f5bcf3 and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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Device Details
Product Details
This product is intended for in vitro diagnostic use in combination with the Atellica IM Analyzer for the quantification of hepatitis B surface antigen (HBsAg) in serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) in human serum and plasma confirmed to be HBsAg positive.
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jun 25, 2024
Jun 25, 2029