Taiwan FDA registration 387bf864fb98e30ac84183c39d6a879d

"Siemens" hepatitis B antibody test reagent set

TW: “西門子”B型肝炎抗體檢驗試劑組

Taiwan·Risk Class 3·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Aug 16, 2023 – Aug 16, 2028Active

Registration details

Analysis ID: 387bf864fb98e30ac84183c39d6a879d
Customs Code: DHA05603621305

Company information

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

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Aug 16, 2023
Expiry Date: Aug 16, 2028

About this record

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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