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"Siemens" hepatitis B antibody test reagent set - Taiwan Registration 387bf864fb98e30ac84183c39d6a879d

Access comprehensive regulatory information for "Siemens" hepatitis B antibody test reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 387bf864fb98e30ac84183c39d6a879d and manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.

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387bf864fb98e30ac84183c39d6a879d
Registration Details
Taiwan FDA Registration: 387bf864fb98e30ac84183c39d6a879d
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Device Details

"Siemens" hepatitis B antibody test reagent set
TW: โ€œ่ฅฟ้–€ๅญโ€Bๅž‹่‚็‚ŽๆŠ—้ซ”ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 3

Registration Details

387bf864fb98e30ac84183c39d6a879d

DHA05603621305

Company Information

United States

Product Details

This product is used for in vitro diagnostics and is used with the Atellica IM Analyzer for the qualitative detection of total antibodies to the core antigen of hepatitis B virus (HBV) in human serum and plasma.

B Hematology, pathology, and genetics

B.4020 Analysis of specific tests

Input;; QMS/QSD

Dates and Status

Aug 16, 2023

Aug 16, 2028