Taiwan FDA registration 629cd0f1d008a95ca34cfc58a18b3f16

"Kaijie" Newmodis BK virus nucleic acid test reagent (unsterilized)

TW: “凱杰” 紐莫帝斯BK病毒核酸檢驗試劑(未滅菌)

Taiwan·Risk Class 1·SENTINEL CH. S.p.A.·Registered Jun 28, 2023 – Jun 28, 2028Active

Registration details

Analysis ID: 629cd0f1d008a95ca34cfc58a18b3f16
Customs Code: DHA09402316506

Company information

Manufacturer: SENTINEL CH. S.p.A.
Manufacturer Country: Italy
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.9999 Miscellaneous
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jun 28, 2023
Expiry Date: Jun 28, 2028

About this record

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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