Taiwan FDA registration 4998bead2bcfeb3b769b07d00522cf0d

Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa

TW: 拜爾發呼吸道病原體多標的核酸檢測試劑組

Taiwan·Risk Class 3·BIOFIRE DIAGNOSTICS, LLC·Registered May 09, 2023 – May 09, 2028Active

Registration details

Analysis ID: 4998bead2bcfeb3b769b07d00522cf0d
Customs Code: DHA05603617306

Company information

Manufacturer: BIOFIRE DIAGNOSTICS, LLC
Manufacturer Country: United States
Authorized Representative: BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)

Product details

Intended Use: This product is used with the multiplex nucleic acid test used in the BioFire FilmArray 2.0 or BioFire FilmArray Torch system for nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory infections (including COVID-19), and for the qualitative detection and identification of multiple respiratory viruses and bacterial nucleic acids.
Product Type (Level 1): B Haematology, pathology and genetics; C Immunology and microbiology
Product Type (Level 2): C.3980 呼吸道病毒多標的核酸檢驗試劑;; B.4020 分析特定試劑
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: May 09, 2023
Expiry Date: May 09, 2028

About this record

Access comprehensive regulatory information for Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 4998bead2bcfeb3b769b07d00522cf0d and manufactured by BIOFIRE DIAGNOSTICS, LLC. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).

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