Taiwan FDA registration 45623f9149204af000a3395841fb6f29
“QIAGEN” artus BK Virus RG PCR kit (Non-sterile)
TW: “凱杰” 阿斯特BK病毒量核酸檢驗試劑組 (未滅菌)
Taiwan·Risk Class 1·MD·QIAGEN GMBH·Registered Jul 02, 2020 – Jul 02, 2025ExpiredRegistration details
- Analysis ID
- 45623f9149204af000a3395841fb6f29
- License Form
- Ministry of Health Medical Device Import No. 021688
- Customs Code
- DHA09402168802
Company information
- Manufacturer
- QIAGEN GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- This product is used with the Rotor-Gene Q instrument to quantify BK virus DNA in human plasma or urine samples in vitro using polymerase chain reaction (PCR).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C9999 Other
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 02, 2020
- Expiry Date
- Jul 02, 2025
About this record
Access comprehensive regulatory information for “QIAGEN” artus BK Virus RG PCR kit (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 45623f9149204af000a3395841fb6f29 and manufactured by QIAGEN GMBH. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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