Taiwan FDA registration c10d496b38b5b81f08fbda64bb9f0eda
Vitex insulin immunoassay correction solution
TW: 維特司胰島素免疫檢測校正液
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered Mar 30, 2021 – Mar 30, 2026ExpiredRegistration details
- Analysis ID
- c10d496b38b5b81f08fbda64bb9f0eda
- Customs Code
- DHA05603438600
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Manufacturer Country
- United Kingdom
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- This product is used to correct the Vitex ECi/ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer, Vitex 5600 Biochemical Immunoassay Analyzer and Vitex 7600 Biochemical Immunoassay Analyzer for the quantitative determination of insulin in human serum and plasma (lithium heparin).
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 Calibrated Products
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Mar 30, 2021
- Expiry Date
- Mar 30, 2026
About this record
Access comprehensive regulatory information for Vitex insulin immunoassay correction solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c10d496b38b5b81f08fbda64bb9f0eda and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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