Multi-standard nucleic acid detection reagent set for microcrystalline pneumonia pathogens - Taiwan Registration 16e3881c4e343bd2a6aa10d28713298a
Access comprehensive regulatory information for Multi-standard nucleic acid detection reagent set for microcrystalline pneumonia pathogens in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 16e3881c4e343bd2a6aa10d28713298a and manufactured by BIOFIRE DIAGNOSTICS, LLC. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).
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Device Details
Product Details
This product is a multiplex nucleic acid test used in conjunction with the FilmArray 2.0 or FilmArray Torch System for specimens of sputum type (induced or coughed up sputum, or endotracheal tube aspirate) or bronchoalveolar lavage (BAL) type specimens (BAL or mini-BAL) obtained from individuals with suspected lower respiratory tract infection , simultaneous detection and identification of multiple respiratory viruses and bacterial nucleic acids and selected antibiotic resistance genes.
C Immunology and microbiology
C.3980 ๅผๅธ้็ ๆฏๅคๆจ็ๆ ธ้ ธๆชข้ฉ่ฉฆๅ
Input;; QMS/QSD
Dates and Status
Aug 27, 2020
Aug 27, 2025