Taiwan FDA registration 8561c6d844ecb45062c3d6deac3b024a
"Siemens" immunoglobulin M analysis reagent
TW: “西門子” 免疫球蛋白M分析試劑
Taiwan·Risk Class 2·RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.·Registered Dec 28, 2018 – Dec 28, 2028ActiveRegistration details
- Analysis ID
- 8561c6d844ecb45062c3d6deac3b024a
- Customs Code
- DHA05603199701
Company information
- Manufacturer Country
- United Kingdom;;United States
- Authorized Representative
- SIEMENS HEALTHCARE LIMITED
Product details
- Intended Use
- This product is used for in vitro diagnosis and needs to be used with Atellica CH Analyzer to quantitatively detect immunoglobulin M (IgM) in human serum and plasma (heparin lithium, EDTA potassium salt).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5510 免疫球蛋白A,G,M,D及E免疫試驗系統
- Import Information
- Input;; Contract manufacturing
Dates and status
- Registration Date
- Dec 28, 2018
- Expiry Date
- Dec 28, 2028
About this record
Access comprehensive regulatory information for "Siemens" immunoglobulin M analysis reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8561c6d844ecb45062c3d6deac3b024a and manufactured by RANDOX LABORATORIES LTD.;; Siemens Healthcare Diagnostics Inc.. The authorized representative in Taiwan is SIEMENS HEALTHCARE LIMITED.
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