Taiwan FDA registration 5606e67fd42651a174cd2d973aed870b
“QIAGEN” artus CMV QS-RGQ Kit
TW: “凱杰” 阿特斯自動化巨細胞病毒核酸檢驗試劑組
Taiwan·Risk Class 2·MD·QIAGEN GMBH·Registered Mar 10, 2017 – Mar 10, 2027ActiveRegistration details
- Analysis ID
- 5606e67fd42651a174cd2d973aed870b
- License Form
- Ministry of Health Medical Device Import No. 029513
- Customs Code
- DHA05602951300
Company information
- Manufacturer
- QIAGEN GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- This product is an in vitro nucleic acid amplification assay for the quantitative determination of cytomegalovirus (CMV) DNA in human plasma. This product is detected using polymerase chain reaction (PCR) and is used with QIAsymphony SP/AS and Rotor-Gene Q instruments.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3175 CMV serum reagent
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 10, 2017
- Expiry Date
- Mar 10, 2027
About this record
Access comprehensive regulatory information for “QIAGEN” artus CMV QS-RGQ Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5606e67fd42651a174cd2d973aed870b and manufactured by QIAGEN GMBH. 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 DatabasePowered by Pure Global AI89,000+ Devices