Taiwan FDA registration 1da598f09a9fb51befb30bd7d2b4e5b3
"Mingjie" Single Step Helicobacter pylori (feces) antigen rapid test reagent (unsterilized)
TW: "明傑" 單一步驟幽門螺旋桿菌(糞便)抗原快速檢測試劑 (未滅菌)
Taiwan·Risk Class 1·Zhejiang Orient Gene Biotech Co.,LTD·Registered Aug 24, 2018 – Aug 24, 2023ExpiredRegistration details
- Analysis ID
- 1da598f09a9fb51befb30bd7d2b4e5b3
- Customs Code
- DHA09600353201
Company information
- Manufacturer
- Zhejiang Orient Gene Biotech Co.,LTD
- Manufacturer Country
- China
- Authorized Representative
- MIN JIER FIRM
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0003 螺旋桿菌屬血清試劑
- Import Information
- Input;; Chinese goods
Dates and status
- Registration Date
- Aug 24, 2018
- Expiry Date
- Aug 24, 2023
About this record
Access comprehensive regulatory information for "Mingjie" Single Step Helicobacter pylori (feces) antigen rapid test 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 1da598f09a9fb51befb30bd7d2b4e5b3 and manufactured by Zhejiang Orient Gene Biotech Co.,LTD. The authorized representative in Taiwan is MIN JIER FIRM.
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