Taiwan FDA registration b213e5fec233bb7cab40b56e74e281d4

Access HIV combo

TW: 亞瑟斯愛滋病毒綜合檢驗試劑組

Taiwan·Risk Class 3·MD·BIO-RAD·Registered Nov 01, 2017 – Nov 01, 2027Active

Registration details

Analysis ID: b213e5fec233bb7cab40b56e74e281d4
License Form: Ministry of Health Medical Device Import No. 030090
Customs Code: DHA05603009001

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 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.
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: Nov 01, 2017
Expiry Date: Nov 01, 2027

About this record

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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