Taiwan FDA registration 5fece09c1a985c2f8541e94ba5ac0f1b
FilmArray Meningitis/Encephalitis Panel (ME)
TW: 微晶腦膜炎/腦炎病原體多標的核酸檢測試劑組
Taiwan·Risk Class 2·MD·BIOFIRE DIAGNOSTICS, LLC·Registered Mar 29, 2017 – Mar 29, 2027ActiveRegistration details
- Analysis ID
- 5fece09c1a985c2f8541e94ba5ac0f1b
- License Form
- Ministry of Health Medical Device Import No. 029524
- Customs Code
- DHA05602952405
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 to qualitatively detect cerebrospinal fluid (CSF) samples collected after lumbar puncture in patients with signs and/or symptoms of meningitis and/or encephalitis, and at the same time detect and identify nucleic acids of a variety of bacteria, viruses and yeasts in the samples.
- 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
- Mar 29, 2017
- Expiry Date
- Mar 29, 2027
About this record
Access comprehensive regulatory information for FilmArray Meningitis/Encephalitis Panel (ME) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5fece09c1a985c2f8541e94ba5ac0f1b 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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