Taiwan FDA registration 26dd8e3f3c759daac629932574b71d4b

"Kaijie" Neomodis Hepatitis C Virus Nucleic Acid Test Reagent Group

TW: "凱杰" 紐莫帝斯 C型肝炎病毒核酸檢驗試劑組

Taiwan·Risk Class 3·NeuMoDx Molecular, Inc.·Registered Jan 23, 2024 – Jan 23, 2029Active

Registration details

Analysis ID: 26dd8e3f3c759daac629932574b71d4b
Customs Code: DHA05603705403

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 genotype 1 to 6 HCV RNA in human plasma and serum samples from patients with hepatitis C virus (HCV) infection with the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System). This product is indicated for adjunct to the management of patients with HCV infection. Not intended as a screening test for blood or blood products, or for diagnosing the clinical status of HCV infection.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jan 23, 2024
Expiry Date: Jan 23, 2029

About this record

Access comprehensive regulatory information for "Kaijie" Neomodis Hepatitis C Virus Nucleic Acid Test Reagent Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 26dd8e3f3c759daac629932574b71d4b and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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