Taiwan FDA registration 68a185c9ba5193a9e672cc7c664ff656
FilmArray Gastrointestinal (GI) Panel
TW: 微晶腸胃道病原體多標的核酸檢測試劑組
Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Dec 01, 2016 – Dec 01, 2026ActiveRegistration details
- Analysis ID
- 68a185c9ba5193a9e672cc7c664ff656
- License Form
- Ministry of Health Medical Device Import No. 029151
- Customs Code
- DHA05602915105
Company information
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Manufacturer Country
- United States
- Authorized Representative
- Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
Product details
- Intended Use
- 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.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C9999 Other
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 01, 2016
- Expiry Date
- Dec 01, 2026
About this record
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 Mérieux S.p.A. Taiwan Branch.
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