Taiwan FDA registration dbef05ecdd10e4846fb40389c4087497

"Kaijie" Neumodis Epstein-Barr Virus Nucleic Acid Test Reagent Set Calibration Solution

TW: "凱杰" 紐莫帝斯 EB 病毒核酸檢驗試劑組校正液

Taiwan·Risk Class 2·NeuMoDx Molecular, Inc.·Registered Feb 01, 2024 – Feb 01, 2029Active

Registration details

Analysis ID: dbef05ecdd10e4846fb40389c4087497
Customs Code: DHA05603705801

Company information

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

Product details

Intended Use: 本產品可搭配 NeuMoDx EBV Quant Assay 2.0 使用,以確立與特定批次 NeuMoDx EBV Quant Test Strip 2.0 相關的校正係數,並在 NeuMoDx 288 Molecular System 或 NeuMoDx 96 Molecular System (NeuMoDx System(s)) 與標準曲線一起使用,以進行準確的定量體外診斷檢測,量化人類血漿樣品中的Epstein-Barr 病毒 (EBV) DNA.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1150 Calibrated Products
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Feb 01, 2024
Expiry Date: Feb 01, 2029

About this record

Access comprehensive regulatory information for "Kaijie" Neumodis Epstein-Barr Virus Nucleic Acid Test Reagent Set Calibration Solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dbef05ecdd10e4846fb40389c4087497 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.

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