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
Taiwan flagTaiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS, INC.·Registered Aug 06, 2021 – Aug 06, 2026Active
Registration details
Analysis ID
37b62882489fb494fa2ab8188ef26bdd
Customs Code
DHA05603488505
Company information
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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