Taiwan FDA registration e25952c8a22ee9d00545b28b665deaa4
Reek Shang calcitonin second generation test reagent
TW: 禮雅尚抑鈣素第二代檢驗試劑
Registration details
- Analysis ID
- e25952c8a22ee9d00545b28b665deaa4
- Customs Code
- DHA05603416000
Company information
- Manufacturer
- DIASORIN INC.
- Manufacturer Country
- United States
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- This product is a one-step sandwich chemofluorescence immunoassay (CLIA) for the quantitative determination of calcitonin in human serum. The results can be combined with other clinical and laboratory data to aid in the diagnosis and management of calcitonin excess or insufficiency. THIS TEST MUST BE PERFORMED ON LIAISON SERIES ANALYZERS (LIAISON AND LIAISON XL).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1140 降血鈣素試驗系統;; A.1660 Quality Material (Analysis Only)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Nov 25, 2020
- Expiry Date
- Nov 25, 2025
About this record
Access comprehensive regulatory information for Reek Shang calcitonin second generation test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e25952c8a22ee9d00545b28b665deaa4 and manufactured by DIASORIN INC.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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