"Kaijie" Neumodis BK virus nucleic acid test reagent set calibration solution - Taiwan Registration 101424cb9b13ad7c62ca56273c833637
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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Device Details
Product Details
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.
A Clinical chemistry and clinical toxicology
A.1150 Calibrated Products
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Sep 08, 2023
Sep 08, 2028