Taiwan FDA registration fc365896e57b7b4f5070f3a4e35395f9

Vitex Human Immunodeficiency Virus Antigen and Antibody Combination Detection Kit Set

TW: 維特司人類免疫缺陷病毒抗原及抗體聯合檢測試劑組

Taiwan·Risk Class 3·ORTHO-CLINICAL DIAGNOSTICS·Registered Dec 08, 2017 – Dec 08, 2027Active

Registration details

Analysis ID: fc365896e57b7b4f5070f3a4e35395f9
Customs Code: DHA05603046808

Company information

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

Product details

Intended Use: This product is used in the Vitex ECi/ECiQ Immunodiagnostic Analyzer, Vitex 3600 Immunodiagnostic Analyzer and Vitex 5600 Biochemical Immunodiagnostic Analyzer to qualitatively detect human immunodeficiency virus type 1 (including group M and O) and/or type 2 (HIV-1 and HIV-2) antibodies and HIV p24 antigen in the serum and plasma (anticoagulant heparin and EDTA) of humans, pregnant women, adolescents and children. The results of this product test, combined with other serological evidence and clinical information, can be used as an adjunct diagnosis of HIV-1 and HIV-2 infection in people at high and low risk of HIV infection.
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 Calibrated Products;; B.4020 Analysis Specific Trial
Import Information: import

Dates and status

Registration Date: Dec 08, 2017
Expiry Date: Dec 08, 2027

About this record

Access comprehensive regulatory information for Vitex Human Immunodeficiency Virus Antigen and Antibody Combination Detection Kit Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number fc365896e57b7b4f5070f3a4e35395f9 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. The authorized representative in Taiwan is DKSH TAIWAN LTD..

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