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“BIO-RAD” Geenius HIV 1/2 Confirmatory Assay and Controls - Taiwan Registration fd1af76f6dc61789621ab0102986249d

Access comprehensive regulatory information for “BIO-RAD” Geenius HIV 1/2 Confirmatory Assay and Controls in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number fd1af76f6dc61789621ab0102986249d and manufactured by BIO-RAD. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.).

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fd1af76f6dc61789621ab0102986249d
Registration Details
Taiwan FDA Registration: fd1af76f6dc61789621ab0102986249d
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Device Details

“BIO-RAD” Geenius HIV 1/2 Confirmatory Assay and Controls
TW: “伯瑞”金能滋 愛滋病毒確認檢驗試劑組
Risk Class 3
MD

Registration Details

fd1af76f6dc61789621ab0102986249d

Ministry of Health Medical Device Import No. 029600

DHA05602960008

Company Information

France

Product Details

This product is a single immunochromatography test that uses fingertip whole blood, venous whole blood, serum or plasma samples to confirm antibodies to immunodeficiency viruses type 1 and type 2 (HIV-1, HIV-2). This product is an additional test for repeated detection of HIV-1 and HIV-2 antibody positive samples. This product should not be used for blood screening.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Jul 31, 2017

Jul 31, 2027