Taiwan FDA registration 32dcd3643323814fc5dfe4740156bf58
Vitex biochemical products glucose-calcium test tablets
TW: 維特司生化產品葡萄糖-鈣試藥片
Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered Aug 10, 2021 – Aug 10, 2026ActiveRegistration details
- Analysis ID
- 32dcd3643323814fc5dfe4740156bf58
- Customs Code
- DHA05603489100
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 Chemistry Analyzer and VITROS XT 7600 Automatic Biochemical Immunoassay Analyzer to quantitatively determine glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid (CSF) and quantitatively determine calcium (Ca) concentration in serum, plasma and urine.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1145 Calcium testing system;; A.1345 Glucose Test System
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 10, 2021
- Expiry Date
- Aug 10, 2026
About this record
Access comprehensive regulatory information for Vitex biochemical products glucose-calcium 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 32dcd3643323814fc5dfe4740156bf58 and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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