Taiwan FDA registration 8fb2016f42555a8cec33b3f9f82b1e80
Vites precalcitonin immunoassay reagent set
TW: 維特司前降鈣素免疫檢測試劑組
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered Oct 28, 2024 – Oct 28, 2029ActiveRegistration details
- Analysis ID
- 8fb2016f42555a8cec33b3f9f82b1e80
- Customs Code
- DHA05603750803
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- 用於 VITROS ECi/ECiQ/3600 免疫診斷分析儀和 VITROS 5600/XT 7600 全自動生化免疫分析儀定量測定人血清和血漿 (肝素鋰和 EDTA) 中的前降鈣素 (PCT).
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 28, 2024
- Expiry Date
- Oct 28, 2029
About this record
Access comprehensive regulatory information for Vites precalcitonin immunoassay reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8fb2016f42555a8cec33b3f9f82b1e80 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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