Xpert HIV-1 Viral Load - Taiwan Registration 4bdbf74b0b5229160ed7501f446fd96d
Access comprehensive regulatory information for Xpert HIV-1 Viral Load in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 4bdbf74b0b5229160ed7501f446fd96d and manufactured by CEPHEID AB. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
4bdbf74b0b5229160ed7501f446fd96d
Ministry of Health Medical Device Import No. 031746
DHA05603174602
Product Details
This product is a reverse transcription polymerase chain reaction (RT-PCR) in vitro diagnostic reagent for the quantification of human immunodeficiency virus type 1 (HIV-1), and HIV-1 RNA in the plasma of infected patients is performed with a fully automated GeneXpert instrument system. This product can be used to quantify HIV-1 M types (subtypes A, B, C, D, E, F, G, H, I, J, K, CRF01_AE, CRF02_AG and CRF03_AB), N and O types, and can quantify HIV-1 RNA from 40 to 10,000,000 copies/ml.
B Hematology and pathology devices
B4020 Analyze specific reagents
Imported from abroad
Dates and Status
Oct 22, 2018
Oct 22, 2028