Access HIV combo - Taiwan Registration b213e5fec233bb7cab40b56e74e281d4
Access comprehensive regulatory information for Access HIV combo in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number b213e5fec233bb7cab40b56e74e281d4 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
Registration Details
b213e5fec233bb7cab40b56e74e281d4
Ministry of Health Medical Device Import No. 030090
DHA05603009001
Product Details
This product uses the Access immunoassay system to qualitatively detect HIV-1 p24 antigen and HIV-1 (M and O) and HIV-2 antibodies in human serum and plasma (Li-heparin, K2-EDTA, K3-EDTA and CPDA-1) using paramagnetic particle chemical cold light immunoassay. This product can be used as a diagnostic aid for HIV-1 and HIV-2 infection and a screening test for blood and plasma donors. This product cannot be used for mixed specimen testing or screening. The test results of this product cannot distinguish between HIV-1 p24 antigen, HIV-1 or HIV-1-O or HIV-2 antibodies.
B Hematology and pathology devices
B4020 Analyze specific reagents
Imported from abroad
Dates and Status
Nov 01, 2017
Nov 01, 2027