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Vitex immunoassay reagent, human immunodeficiency virus antigen and antibody combination quality control solution - Taiwan Registration fc89191b55ca152a1796bf929b82ab7e

Access comprehensive regulatory information for Vitex immunoassay reagent, human immunodeficiency virus antigen and antibody combination 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 fc89191b55ca152a1796bf929b82ab7e and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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fc89191b55ca152a1796bf929b82ab7e
Registration Details
Taiwan FDA Registration: fc89191b55ca152a1796bf929b82ab7e
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Device Details

Vitex immunoassay reagent, human immunodeficiency virus antigen and antibody combination quality control solution
TW: ็ถญ็‰นๅธๅ…็–ซๆชข้ฉ—่ฉฆๅŠ‘ไบบ้กžๅ…็–ซ็ผบ้™ท็—…ๆฏ’ๆŠ—ๅŽŸๅŠๆŠ—้ซ”่ฏๅˆๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

fc89191b55ca152a1796bf929b82ab7e

DHA05603617701

Company Information

United Kingdom

Product Details

To monitor the performance of antibodies to human immunodeficiency virus (including antibodies type 1 and/or type 2, antibody type 1 Otyping, and p24 antigen) on the Vitex Immunodiagnostic Analyzer and Biochemical Immunoassay Analyzer on the Vitex ECi/ECiQ/3600 Immunodiagnostic Analyzer and the Vitex 5600/XT 7600 Biochemical Immunoassay Analyzer.

A Clinical chemistry and clinical toxicology

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

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

May 19, 2023

May 19, 2028