Positive Blood Culture Identification And Ast Kit
The Positive Blood Culture Identification and AST Kit is an in vitro diagnostic kit using fluorescence in situ hybridization (FISH) for simultaneous identification and quantitative antimicrobial susceptibility testing (AST) of multiple microbial targets directly from positive blood culture specimens. It is classified as FDA Class 2 under 21 CFR 866.1650 in the Microbiology specialty, requiring 510(k) premarket notification. The device aids in rapid pathogen identification and guides antibiotic therapy selection. Product code PRH; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PRH
- Device Class
- FDA class 2
- Regulation Number
- 866.1650
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.