FilmArray Meningitis/Encephalitis Panel (ME) - Taiwan Registration 5fece09c1a985c2f8541e94ba5ac0f1b
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 Mรฉrieux S.p.A. Taiwan Branch.
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Device Details
Registration Details
5fece09c1a985c2f8541e94ba5ac0f1b
Ministry of Health Medical Device Import No. 029524
DHA05602952405
Product Details
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.
C Immunology and microbiology devices
C9999 Other
Imported from abroad
Dates and Status
Mar 29, 2017
Mar 29, 2027