Taiwan FDA registration 12400bf2c0d4a59f3adb48b751a57959
"Kaijie" Newmodis EBV nucleic acid external quality control material (unsterilized)
TW: "凱杰" 紐莫帝斯EB病毒核酸外部品管材料(未滅菌)
Taiwan·Risk Class 1·NeuMoDx Molecular, Inc.·Registered Aug 18, 2022 – Aug 18, 2027ActiveRegistration details
- Analysis ID
- 12400bf2c0d4a59f3adb48b751a57959
- Customs Code
- DHA09402287506
Company information
- Manufacturer
- NeuMoDx Molecular, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- Limited to the classification and grading management of medical equipment, quality control materials (analytical and non-analytical) (A.1660) the first level identification range.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Aug 18, 2022
- Expiry Date
- Aug 18, 2027
About this record
Access comprehensive regulatory information for "Kaijie" Newmodis EBV nucleic acid external quality control material (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 12400bf2c0d4a59f3adb48b751a57959 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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