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“QIAGEN” QuantiFERON-TB Gold (QFT) - Taiwan Registration 59b9d81f07d66b54b1911b76e08e2868

Access comprehensive regulatory information for “QIAGEN” QuantiFERON-TB Gold (QFT) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 59b9d81f07d66b54b1911b76e08e2868 and manufactured by QIAGEN. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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59b9d81f07d66b54b1911b76e08e2868
Registration Details
Taiwan FDA Registration: 59b9d81f07d66b54b1911b76e08e2868
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Device Details

“QIAGEN” QuantiFERON-TB Gold (QFT)
TW: “凱杰” 克肺癆結核菌感染診斷試管組
Risk Class 3
MD

Registration Details

59b9d81f07d66b54b1911b76e08e2868

Ministry of Health Medical Device Import No. 027706

DHA05602770601

Company Information

United States

Product Details

This product is an in vitro diagnostic reagent, which uses peptide [ESAT-6, CFP-10, TB7.7 (p4)] to stimulate cells in heparinized whole blood, and then determines the interferon-γ produced by the in vitro reaction of the peptide antigen by enzyme link immunosorbent analysis to determine whether it is infected by tuberculosis.

B Hematology and pathology devices

B4020 Analyze specific reagents

Imported from abroad

Dates and Status

Oct 05, 2015

Oct 05, 2025