Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa - Taiwan Registration 4998bead2bcfeb3b769b07d00522cf0d
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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Device Details
Product Details
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.
B Haematology, pathology and genetics; C Immunology and microbiology
C.3980 ๅผๅธ้็ ๆฏๅคๆจ็ๆ ธ้ ธๆชข้ฉ่ฉฆๅ;; B.4020 ๅๆ็นๅฎ่ฉฆๅ
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
May 09, 2023
May 09, 2028