Taiwan FDA registration 869eedf3325241aecbbe7f48a3e8338b
"Kaijie" Newmodis Epstein-Barr virus nucleic acid test set (unsterilized)
TW: "凱杰" 紐莫帝斯EB病毒核酸檢驗試劑組(未滅菌)
Taiwan·Risk Class 1·NeuMoDx Molecular, Inc.·Registered Sep 28, 2022 – Sep 28, 2027ActiveRegistration details
- Analysis ID
- 869eedf3325241aecbbe7f48a3e8338b
- Customs Code
- DHA09402291008
Company information
- Manufacturer
- NeuMoDx Molecular, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- Limited to the first level identification range of the classification and grading management method for medical devices "Ebr virus serum reagent (C.3235)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3235 EB病毒血清試劑
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 28, 2022
- Expiry Date
- Sep 28, 2027
About this record
Access comprehensive regulatory information for "Kaijie" Newmodis Epstein-Barr virus nucleic acid test set (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 869eedf3325241aecbbe7f48a3e8338b and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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