"Siemens" hepatitis B core immunoglobulin M antibody test kit - Taiwan Registration 8e6468a748a09709355eb1b1a01d6cd3
Access comprehensive regulatory information for "Siemens" hepatitis B core immunoglobulin M antibody test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 8e6468a748a09709355eb1b1a01d6cd3 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 used for in vitro diagnostics in conjunction with the Atellica IM Analyzer for the qualitative detection of IgM in response to the hepatitis B virus core antigen (hepatitis B virus core antibody IgM) in human serum and plasma (EDTA, lithium heparin, and heparin sodium).
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
Aug 10, 2023
Aug 10, 2028