Taiwan FDA registration 406ea9fbced7da8b0a815268b4287b06
"Abel gene" is a reagent for the detection of Clostridium difficile
TW: “艾柏基因” 困難梭狀芽孢桿菌檢測試劑
Taiwan·Risk Class 2·HIBERGENE DIAGNOSTICS·Registered Aug 27, 2020 – Aug 27, 2025ExpiredRegistration details
- Analysis ID
- 406ea9fbced7da8b0a815268b4287b06
- Customs Code
- DHA05603353805
Company information
- Manufacturer
- HIBERGENE DIAGNOSTICS
- Manufacturer Country
- Ireland
- Authorized Representative
- YOULUM BIOTECHNOLOGY CO., LTD.
Product details
- Intended Use
- This product is equipped with the HG Swift instrument, which is a LAMP-based molecular diagnostic test used to detect Clostridium difficile in human stool samples.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3130 困難梭狀桿菌毒素基因擴增試劑
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Aug 27, 2020
- Expiry Date
- Aug 27, 2025
About this record
Access comprehensive regulatory information for "Abel gene" is a reagent for the detection of Clostridium difficile in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 406ea9fbced7da8b0a815268b4287b06 and manufactured by HIBERGENE DIAGNOSTICS. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..
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