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"Vitex" immunoassay reagent HBe quality control solution - Taiwan Registration 33ec2a8e24b4a8d05fbecf43058b38e5

Access comprehensive regulatory information for "Vitex" immunoassay reagent HBe quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 33ec2a8e24b4a8d05fbecf43058b38e5 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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33ec2a8e24b4a8d05fbecf43058b38e5
Registration Details
Taiwan FDA Registration: 33ec2a8e24b4a8d05fbecf43058b38e5
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Device Details

"Vitex" immunoassay reagent HBe quality control solution
TW: "็ถญ็‰นๅธ" ๅ…็–ซๆชข้ฉ—่ฉฆๅŠ‘HBeๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

33ec2a8e24b4a8d05fbecf43058b38e5

DHA05603586504

Company Information

United Kingdom

Product Details

This product is used on the Vitex ECi/ECiQ/3600 Immunodiagnostic Analyzer and the Vitex 5600/XT 7600 Biochemical Immunoassay Analyzer to monitor the performance of the analyzers for the determination of Anti-HBe and HBeAg.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical)

Input;; QMS/QSD

Dates and Status

Oct 19, 2022

Oct 19, 2027