Taiwan FDA registration 0e40d853910a101ae5ff235d138ef60e

“QIAGEN” QuantiFERON-TB Gold Plus (QFT-Plus)

TW: “凱杰”克肺癆結核菌感染診斷升級套組

Taiwan·Risk Class 3·MD·QIAGEN·Registered Aug 29, 2019 – Aug 29, 2024Expired

Registration details

Analysis ID: 0e40d853910a101ae5ff235d138ef60e
License Form: Ministry of Health Medical Device Import No. 032488
Customs Code: DHA05603248801

Company information

Manufacturer: QIAGEN
Manufacturer Country: United States
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: 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.
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: Aug 29, 2019
Expiry Date: Aug 29, 2024

About this record

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.