Taiwan FDA registration e6325554565d202973cb7e97c8f5bcf3

"Siemens" hepatitis B surface antigen quantification kit

TW: "西門子" B型肝炎表面抗原定量試劑組

Taiwan·Risk Class 3·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Jun 25, 2024 – Jun 25, 2029Active

Registration details

Analysis ID: e6325554565d202973cb7e97c8f5bcf3
Customs Code: DHA05603708603

Company information

Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Country: United States
Authorized Representative: SIEMENS HEALTHCARE LIMITED

Product details

Intended Use: 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.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Jun 25, 2024
Expiry Date: Jun 25, 2029

About this record

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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