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"Abel gene" is a reagent for the detection of Clostridium difficile - Taiwan Registration 406ea9fbced7da8b0a815268b4287b06

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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406ea9fbced7da8b0a815268b4287b06
Registration Details
Taiwan FDA Registration: 406ea9fbced7da8b0a815268b4287b06
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Device Details

"Abel gene" is a reagent for the detection of Clostridium difficile
TW: โ€œ่‰พๆŸๅŸบๅ› โ€ ๅ›ฐ้›ฃๆขญ็‹€่Šฝๅญขๆกฟ่Œๆชขๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

406ea9fbced7da8b0a815268b4287b06

DHA05603353805

Company Information

Ireland

Product Details

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.

C Immunology and microbiology

C.3130 ๅ›ฐ้›ฃๆขญ็‹€ๆกฟ่Œๆฏ’็ด ๅŸบๅ› ๆ“ดๅขž่ฉฆๅŠ‘

Input;; QMS/QSD

Dates and Status

Aug 27, 2020

Aug 27, 2025