Second-generation reagent set for nucleic acid detection with multiple standards for the identification of blood cultures by Bayerfa - Taiwan Registration 8c0e7cb229499834f96faf716f2c2a64
Access comprehensive regulatory information for Second-generation reagent set for nucleic acid detection with multiple standards for the identification of blood cultures by Bayerfa in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8c0e7cb229499834f96faf716f2c2a64 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 with FilmArray 2.0 or FilmArray Torch system, which can simultaneously detect and identify nucleic acids of a variety of bacteria and yeasts, as well as the genetic determinants of specific antibiotic resistance, and can be directly used in blood culture samples identified as positive by continuous monitoring blood culture systems, and the test results of this product can be interpreted with Gram stain results.
C Immunology and microbiology
C.3365 Multi-label nucleic acid test reagents for the identification of microbial and antimicrobial resistance markers in positive blood cultures
Input;; QMS/QSD
Dates and Status
Jan 27, 2021
Jan 27, 2026