Pure Global

“QIAGEN” QuantiFERON-TB Gold Plus (QFT-Plus) - Taiwan Registration 0e40d853910a101ae5ff235d138ef60e

Access comprehensive regulatory information for “QIAGEN” QuantiFERON-TB Gold Plus (QFT-Plus) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 0e40d853910a101ae5ff235d138ef60e and manufactured by QIAGEN. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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.

Free Database
Powered by Pure Global AI
89,000+ Devices
0e40d853910a101ae5ff235d138ef60e
Registration Details
Taiwan FDA Registration: 0e40d853910a101ae5ff235d138ef60e
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

“QIAGEN” QuantiFERON-TB Gold Plus (QFT-Plus)
TW: “凱杰”克肺癆結核菌感染診斷升級套組
Risk Class 3
MD

Registration Details

0e40d853910a101ae5ff235d138ef60e

Ministry of Health Medical Device Import No. 032488

DHA05603248801

Company Information

United States

Product Details

This product is an in vitro diagnostic detection reagent, using ESAT-6 and CFP-10 peptide antigen to stimulate cells in heparinized whole blood, and using enzyme immunoassay (ELISA) to detect interferon (IFN-γ) produced by the in vitro reaction of peptide antigen to determine whether it is infected by tuberculosis. This product is a test for indirect detection of tuberculosis infection, including morbidity, and is evaluated in conjunction with risk assessment, radiography, and other medical and diagnostic results.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Aug 29, 2019

Aug 29, 2024