"Kaijie" Newmodis BK virus nucleic acid test reagent (unsterilized) - Taiwan Registration 629cd0f1d008a95ca34cfc58a18b3f16
Access comprehensive regulatory information for "Kaijie" Newmodis BK virus nucleic acid test reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 629cd0f1d008a95ca34cfc58a18b3f16 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 an automated in vitro nucleic acid amplification assay that uses NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System to identify and quantify BK virus DNA from human plasma, serum and urine samples using real-time polymerase chain reaction (PCR). The results of this product test must be evaluated in conjunction with other relevant clinical and laboratory results to aid in the diagnosis and monitoring of BK virus infection.
C Immunology and microbiology
C.9999 Miscellaneous
Input;; QMS/QSD
Dates and Status
Jun 28, 2023
Jun 28, 2028