Taiwan FDA registration 37b62882489fb494fa2ab8188ef26bdd
Vitex biochemical product albumin-total protein test tablets
TW: 維特司生化產品白蛋白-總蛋白質試藥片
Registration details
- Analysis ID
- 37b62882489fb494fa2ab8188ef26bdd
- Customs Code
- DHA05603488505
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 7600 Automatic Biochemical Immunology Analyzer and VITROS XT 3400 Automatic Biochemistry Analyzer to quantitatively determine albumin (ALB) concentration in serum and plasma and quantitatively determine total protein (TP) concentration in serum and plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1035 Albumin testing system;; A.1635 Total Protein Testing System
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 06, 2021
- Expiry Date
- Aug 06, 2026
About this record
Access comprehensive regulatory information for Vitex biochemical product albumin-total protein 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 37b62882489fb494fa2ab8188ef26bdd and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..
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