Taiwan FDA registration 3e2a7cf98638474f9ae3328b580956e3

"Kaijie" Neumodis cytomegalovirus nucleic acid test kit

TW: "凱杰" 紐莫帝斯巨細胞病毒核酸檢驗試劑組

Taiwan·Risk Class 2·NeuMoDx Molecular, Inc.·Registered Jan 09, 2024 – Jan 09, 2029Active

Registration details

Analysis ID: 3e2a7cf98638474f9ae3328b580956e3
Customs Code: DHA05603705100

Company information

Manufacturer: NeuMoDx Molecular, Inc.
Manufacturer Country: United States
Authorized Representative: QIAGEN TAIWAN COMPANY LIMITED

Product details

Intended Use: This product is an automated, in vitro nucleic acid amplification assay for the quantification of CMV DNA from the CMV genotype gB1 to gB4 in human plasma samples from patients infected with cytomegalovirus (CMV).
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): C.3175 Giant cell disease poison serum test;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jan 09, 2024
Expiry Date: Jan 09, 2029

About this record

Access comprehensive regulatory information for "Kaijie" Neumodis cytomegalovirus nucleic acid test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3e2a7cf98638474f9ae3328b580956e3 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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