Taiwan FDA registration fd1af76f6dc61789621ab0102986249d
“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
Taiwan·Risk Class 3·MD·BIO-RAD·Registered Jul 31, 2017 – Jul 31, 2027ActiveRegistration details
- Analysis ID
- fd1af76f6dc61789621ab0102986249d
- License Form
- Ministry of Health Medical Device Import No. 029600
- Customs Code
- DHA05602960008
Company information
- Manufacturer
- BIO-RAD
- Manufacturer Country
- France
- Authorized Representative
- Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- B Hematology and pathology devices
- Product Type (Level 2)
- B4020 Analyze specific reagents
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 31, 2017
- Expiry Date
- Jul 31, 2027
About this record
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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