Taiwan FDA registration 40a6675e6c34335836bb5b441a6c9dac

Second-generation amplification reagent set for multi-standard nucleic acid detection of microcrystalline respiratory pathogens

TW: 微晶呼吸道病原體多標的核酸檢測第二代擴增試劑組
Taiwan flagTaiwan·Risk Class 2·BIOFIRE DIAGNOSTICS, LLC·Registered Jul 27, 2020 – Jul 27, 2025Expired
Registration details
Analysis ID
40a6675e6c34335836bb5b441a6c9dac
Customs Code
DHA05603351901
Company information
Manufacturer Country
United States
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order.
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
QMS/QSD;; 輸入
Dates and status
Registration Date
Jul 27, 2020
Expiry Date
Jul 27, 2025
About this record

Access comprehensive regulatory information for Second-generation amplification reagent set for multi-standard nucleic acid detection of microcrystalline respiratory pathogens in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 40a6675e6c34335836bb5b441a6c9dac and manufactured by BIOFIRE DIAGNOSTICS, LLC. The authorized representative in Taiwan is BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG).

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