Taiwan FDA registration 59b9d81f07d66b54b1911b76e08e2868
“QIAGEN” QuantiFERON-TB Gold (QFT)
TW: “凱杰” 克肺癆結核菌感染診斷試管組
Taiwan·Risk Class 3·MD·QIAGEN·Registered Oct 05, 2015 – Oct 05, 2025ExpiredRegistration details
- Analysis ID
- 59b9d81f07d66b54b1911b76e08e2868
- License Form
- Ministry of Health Medical Device Import No. 027706
- Customs Code
- DHA05602770601
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 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.
- 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
- Oct 05, 2015
- Expiry Date
- Oct 05, 2025
About this record
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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