Taiwan FDA registration fc89191b55ca152a1796bf929b82ab7e

Vitex immunoassay reagent, human immunodeficiency virus antigen and antibody combination quality control solution

TW: 維特司免疫檢驗試劑人類免疫缺陷病毒抗原及抗體聯合品管液

Taiwan·Risk Class 2·ORTHO-CLINICAL DIAGNOSTICS·Registered May 19, 2023 – May 19, 2028Active

Registration details

Analysis ID: fc89191b55ca152a1796bf929b82ab7e
Customs Code: DHA05603617701

Company information

Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Manufacturer Country: United Kingdom
Authorized Representative: DKSH TAIWAN LTD.

Product details

Intended Use: 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.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical)
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: May 19, 2023
Expiry Date: May 19, 2028

About this record

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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