Taiwan FDA registration 0ef3f4a1a6fe918b7fb45795c01d750f
Vitex biochemical products urea nitrogen-creatinine test tablets
TW: 維特司生化產品尿素氮-肌酸酐試藥片
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered Aug 09, 2021 – Aug 09, 2026ActiveRegistration details
- Analysis ID
- 0ef3f4a1a6fe918b7fb45795c01d750f
- Customs Code
- DHA05603489001
Company information
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Manufacturer Country
- United States
- Authorized Representative
- DKSH TAIWAN LTD.
Product details
- Intended Use
- Use this product on the VITROS XT 3400 Automatic Biochemistry Analyzer and VITROS XT 7600 Automatic Biochemical Immunoassay Analyzer to quantitatively determine urea nitrogen concentrations in serum, plasma and urine (reported as urea nitrogen or urea) and quantitatively determine creatinine (CREA) concentrations in serum, plasma and urine.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1225 肌氨酸酐試驗系統(Creatininetestsystem);; A.1770 尿素氮試驗系統
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 09, 2021
- Expiry Date
- Aug 09, 2026
About this record
Access comprehensive regulatory information for Vitex biochemical products urea nitrogen-creatinine test tablets in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0ef3f4a1a6fe918b7fb45795c01d750f and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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