Second-generation reagent set for nucleic acid detection with multiple standards for the identification of blood cultures by Bayerfa
Taiwan·Risk Class 2·BIOFIRE DIAGNOSTICS, LLC·Registered Jan 27, 2021 – Jan 27, 2026Expired- Analysis ID
- 8c0e7cb229499834f96faf716f2c2a64
- Customs Code
- DHA05603435400
- 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 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.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3365 Multi-label nucleic acid test reagents for the identification of microbial and antimicrobial resistance markers in positive blood cultures
- Import Information
- Input;; QMS/QSD
- Registration Date
- Jan 27, 2021
- Expiry Date
- Jan 27, 2026
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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