Taiwan FDA registration 101424cb9b13ad7c62ca56273c833637
"Kaijie" Neumodis BK virus nucleic acid test reagent set calibration solution
TW: "凱杰" 紐莫帝斯BK病毒核酸檢驗試劑組校正液
Taiwan·Risk Class 2·SENTINEL CH. S.p.A.·Registered Sep 08, 2023 – Sep 08, 2028ActiveRegistration details
- Analysis ID
- 101424cb9b13ad7c62ca56273c833637
- Customs Code
- DHA05603621904
Company information
- Manufacturer
- SENTINEL CH. S.p.A.
- Manufacturer Country
- Italy
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- This product is used with the NeuMoDx BKV Quant Assay to establish the correction factor associated with a specific NeuMoDx BKV Quant Test Strip lot and to perform in vitro diagnostic tests on the NeuMoDx 288 Molecular System or NeuMoDx 96 Molecular System (NeuMoDx System) in conjunction with a standard curve to quantify human plasma/ BK virus DNA in serum and urine samples.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1150 Calibrated Products
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Sep 08, 2023
- Expiry Date
- Sep 08, 2028
About this record
Access comprehensive regulatory information for "Kaijie" Neumodis BK virus nucleic acid test reagent set calibration solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 101424cb9b13ad7c62ca56273c833637 and manufactured by SENTINEL CH. S.p.A.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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