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Vitex Biochemical Total Bilirubin-Alkaline Phosphatase Test Tablets - Taiwan Registration 18c9a2f98a0427b096958e09770083aa

Access comprehensive regulatory information for Vitex Biochemical Total Bilirubin-Alkaline Phosphatase 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 18c9a2f98a0427b096958e09770083aa and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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18c9a2f98a0427b096958e09770083aa
Registration Details
Taiwan FDA Registration: 18c9a2f98a0427b096958e09770083aa
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Device Details

Vitex Biochemical Total Bilirubin-Alkaline Phosphatase Test Tablets
TW: ็ถญ็‰นๅธ็”ŸๅŒ–็”ขๅ“็ธฝ่†ฝ็ด…็ด -้นผๆ€ง็ฃท้…ธ้…ถ่ฉฆ่—ฅ็‰‡
Risk Class 2

Registration Details

18c9a2f98a0427b096958e09770083aa

DHA05603521708

Company Information

United States

Product Details

With the VITROS XT 3400 and VITROS XT 7600 Biochemical Immunoassay Analyzer, TBIL and ALKP detection reagents were used to quantitatively determine the total bilirubin (TBIL) concentration and alkaline phosphatase (ALKP) activity in serum and plasma, respectively.

A Clinical chemistry and clinical toxicology

A.1050 Alkaline phosphatase or isoenzyme testing system;; A.1110 Bilirubin (total or direct) test system

Input;; QMS/QSD

Dates and Status

Feb 08, 2022

Feb 08, 2027