Taiwan FDA registration 1539403171074ddd0146ee4555be8c7d
Arthurs HIV Comprehensive Test Set 2nd generation
TW: 亞瑟斯愛滋病毒綜合檢驗試劑組 第二代
Taiwan·Risk Class 3·BIO-RAD·Registered Nov 15, 2024 – Nov 15, 2029ActiveRegistration details
- Analysis ID
- 1539403171074ddd0146ee4555be8c7d
- Customs Code
- DHA05603751401
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 semi-quantitative chemiluminescent immunoassay (CLIA) using paramagnetic beads, which uses the Access immunoassay system to detect HIV-1 and HIV-2 HIV-1 and HIV-2 p26 antigens and antibodies in human serum or plasma. This analysis method can be used as an adjunct to the diagnosis of HIV infection and as a screening tool for blood and plasma donors.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Nov 15, 2024
- Expiry Date
- Nov 15, 2029
About this record
Access comprehensive regulatory information for Arthurs HIV Comprehensive Test Set 2nd generation in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 1539403171074ddd0146ee4555be8c7d and manufactured by BIO-RAD. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.).
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