Arthurs HIV Comprehensive Test Set 2nd generation - Taiwan Registration 1539403171074ddd0146ee4555be8c7d
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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Device Details
Product Details
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.
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.4020 Analysis of specific tests
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Nov 15, 2024
Nov 15, 2029