Taiwan FDA registration e890fae7c0848c09c3c21827c9405203
"Kaijie" Neumodis B Streptococcus Detection Reagent (Unsterilized)
TW: "凱杰" 紐莫帝斯B群鏈球菌檢測試劑 (未滅菌)
Taiwan·Risk Class 1·NeuMoDx Molecular, Inc.·Registered Aug 24, 2022 – Aug 24, 2027ActiveRegistration details
- Analysis ID
- e890fae7c0848c09c3c21827c9405203
- Customs Code
- DHA09402288101
Company information
- Manufacturer
- NeuMoDx Molecular, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- QIAGEN TAIWAN COMPANY LIMITED
Product details
- Intended Use
- Classification and grading management method of medical equipment: Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3740 鏈球菌屬血清試劑
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Aug 24, 2022
- Expiry Date
- Aug 24, 2027
About this record
Access comprehensive regulatory information for "Kaijie" Neumodis B Streptococcus Detection Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number e890fae7c0848c09c3c21827c9405203 and manufactured by NeuMoDx Molecular, Inc.. The authorized representative in Taiwan is QIAGEN TAIWAN COMPANY LIMITED.
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