Taiwan FDA registration b50e57bfe17bbc253093ae98fa1ed9ec
"Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized)
TW: “亞培”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·ABON BIOPHARM (HANGZHOU) CO., LTD·Registered Aug 22, 2023 – Aug 22, 2028ActiveRegistration details
- Analysis ID
- b50e57bfe17bbc253093ae98fa1ed9ec
- Customs Code
- DHA09600481604
Company information
- Manufacturer
- ABON BIOPHARM (HANGZHOU) CO., LTD
- Manufacturer Country
- China
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum 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
- QMS/QSD;; Chinese goods;; input
Dates and status
- Registration Date
- Aug 22, 2023
- Expiry Date
- Aug 22, 2028
About this record
Access comprehensive regulatory information for "Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b50e57bfe17bbc253093ae98fa1ed9ec and manufactured by ABON BIOPHARM (HANGZHOU) CO., LTD. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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