Taiwan FDA registration 8e6468a748a09709355eb1b1a01d6cd3
"Siemens" hepatitis B core immunoglobulin M antibody test kit
TW: “西門子” B型肝炎核心免疫球蛋白M抗體檢驗試劑組
Taiwan·Risk Class 3·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Registered Aug 10, 2023 – Aug 10, 2028ActiveRegistration details
- Analysis ID
- 8e6468a748a09709355eb1b1a01d6cd3
- Customs Code
- DHA05603621101
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 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).
- 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
- Aug 10, 2023
- Expiry Date
- Aug 10, 2028
About this record
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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