Taiwan FDA registration bdabd7e9606183b723208b84567601e4
"Vitex" thyrotropin immunoassay group
TW: "維特司" 促甲狀腺素免疫檢測試劑組
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered Jan 16, 2023 – Jan 16, 2028ActiveRegistration details
- Analysis ID
- bdabd7e9606183b723208b84567601e4
- Customs Code
- DHA05603615109
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- For the quantitative determination of thyroid-stimulating hormone (TSH) in human serum and plasma (EDTA and heparin). Required for use with the VITROS ECi/ECiQ Immunodiagnostic Analyzer, VITROS 3600 Immunodiagnostic Analyzer and VITROS 5600/XT 7600 Biochemical Immunoassay Analyzer.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 Calibrated Products;; A.1690 甲狀gland 剌激荷爾蒙試驗系統
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jan 16, 2023
- Expiry Date
- Jan 16, 2028
About this record
Access comprehensive regulatory information for "Vitex" thyrotropin immunoassay group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number bdabd7e9606183b723208b84567601e4 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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