Multi-standard nucleic acid detection reagent set for microcrystalline pneumonia pathogens
Taiwan·Risk Class 2·BIOFIRE DIAGNOSTICS, LLC·Registered Aug 27, 2020 – Aug 27, 2025Expired- Analysis ID
- 16e3881c4e343bd2a6aa10d28713298a
- Customs Code
- DHA05603353703
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Manufacturer Country
- United States
- Authorized Representative
- BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
- Intended Use
- 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.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3980 呼吸道病毒多標的核酸檢驗試劑
- Import Information
- Input;; QMS/QSD
- Registration Date
- Aug 27, 2020
- Expiry Date
- Aug 27, 2025
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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