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FilmArray Gastrointestinal (GI) Panel - Taiwan Registration 68a185c9ba5193a9e672cc7c664ff656

Access comprehensive regulatory information for FilmArray Gastrointestinal (GI) Panel in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 68a185c9ba5193a9e672cc7c664ff656 and manufactured by BIOFIRE DIAGNOSTICS, LLC. The authorized representative in Taiwan is Hong Kong Commercial Mรฉrieux S.p.A. Taiwan Branch.

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68a185c9ba5193a9e672cc7c664ff656
Registration Details
Taiwan FDA Registration: 68a185c9ba5193a9e672cc7c664ff656
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Device Details

FilmArray Gastrointestinal (GI) Panel
TW: ๅพฎๆ™ถ่…ธ่ƒƒ้“็—…ๅŽŸ้ซ”ๅคšๆจ™็š„ๆ ธ้…ธๆชขๆธฌ่ฉฆๅŠ‘็ต„
Risk Class 2
MD

Registration Details

68a185c9ba5193a9e672cc7c664ff656

Ministry of Health Medical Device Import No. 029151

DHA05602915105

Company Information

Product Details

This product is equipped with the FilmArray system, which uses multiple nucleic acid sequences for qualitative detection, and has signs and/or symptoms of gastrointestinal infection and collects stool samples in Cary Blair delivery medium, which can simultaneously detect and identify nucleic acids of a variety of bacteria, viruses and parasites in the sample.

C Immunology and microbiology devices

C9999 Other

Imported from abroad

Dates and Status

Dec 01, 2016

Dec 01, 2026