Taiwan FDA registration 5ad4eb630addfb0d0c27b196fb213e01

"Kaijie" Neomodis Hepatitis B Virus Nucleic Acid Test Reagent Set

TW: "凱杰" 紐莫帝斯 B 型肝炎病毒核酸檢驗試劑組

Taiwan·Risk Class 3·NeuMoDx Molecular, Inc.·Registered Aug 24, 2023 – Aug 24, 2028Active

Registration details

Analysis ID: 5ad4eb630addfb0d0c27b196fb213e01
Customs Code: DHA05603621509

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 use with the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System) for the quantification of HBV DNA from HBV genotypes A to H in human plasma and serum samples for patients infected with hepatitis B virus (HBV). This product is suitable for adjuvant treatment of patients with HBV infection. It is not intended as a screening test for blood or blood products, or as a diagnostic tool for the clinical status of HBV 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: Aug 24, 2023
Expiry Date: Aug 24, 2028

About this record

Access comprehensive regulatory information for "Kaijie" Neomodis Hepatitis B Virus Nucleic Acid Test Reagent Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5ad4eb630addfb0d0c27b196fb213e01 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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