Taiwan FDA registration 94f5108500b84ae263edee3dba8249d9
"Kaijie" Numodis multi-standard nucleic acid automatic detection system
TW: "凱杰" 紐莫帝斯多標的核酸自動化檢測系統
Taiwan·Risk Class 2·NeuMoDx Molecular, Inc.·Registered Mar 29, 2023 – Mar 29, 2028ActiveRegistration details
- Analysis ID
- 94f5108500b84ae263edee3dba8249d9
- Customs Code
- DHA05603616303
Company information
- Manufacturer
- NeuMoDx Molecular, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- This product can automatically extract and isolate nucleic acids from a variety of sample types, and use fluorescence-based PCR to automatically amplify and detect the target nucleic acid sequence.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2570 Clinical Multi-standard Detection System Instrument
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Mar 29, 2023
- Expiry Date
- Mar 29, 2028
About this record
Access comprehensive regulatory information for "Kaijie" Numodis multi-standard nucleic acid automatic detection system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 94f5108500b84ae263edee3dba8249d9 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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