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"Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized) - Taiwan Registration b50e57bfe17bbc253093ae98fa1ed9ec

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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b50e57bfe17bbc253093ae98fa1ed9ec
Registration Details
Taiwan FDA Registration: b50e57bfe17bbc253093ae98fa1ed9ec
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Device Details

"Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized)
TW: โ€œไบžๅŸนโ€ๅ–ฎไธ€ๆญฅ้ฉŸๅนฝ้–€่žบๆ—‹ๆกฟ่Œ(็ณžไพฟ)ๆŠ—ๅŽŸๅฟซ้€Ÿๆชขๆธฌ่ฉฆๅŠ‘(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

b50e57bfe17bbc253093ae98fa1ed9ec

DHA09600481604

Company Information

Product Details

Limited to the classification and grading management of medical devices, the first level identification range of "Helicobacter serum reagent (C.0003)".

C Immunology and microbiology

C.0003 ่žบๆ—‹ๆกฟ่Œๅฑฌ่ก€ๆธ…่ฉฆๅŠ‘

QMS/QSD;; Chinese goods;; input

Dates and Status

Aug 22, 2023

Aug 22, 2028