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rapid fermentation agar rfa
Remel
Summary: The Rapid Fermentation Agar RFA by Remel is a diagnostic tool used primarily in microbiology labs to identify and differentiate microorganisms based on their fermentation capabilities. It is typically used by laboratory technicians and microbiologists.
FDA Clearance Information
Pathway
510K
Number
K800734 ↗
Decision Date
May 8, 1980
Product Code
JSE
Device Class
Class 1
Evidence
0 studies
The Rapid Fermentation Agar RFA was cleared through the FDA 510(k) pathway on May 8, 1980. Manufactured by Remel, it is classified as a Class 1 device under product code JSE.
What It Is
The Rapid Fermentation Agar RFA is a culture medium designed to facilitate the rapid identification of microorganisms by observing their fermentation reactions. It works by providing a nutrient-rich environment where specific bacteria can grow and produce characteristic changes in the medium, such as color shifts, which indicate fermentation activity. This tool is essential for microbiologists in clinical laboratories to quickly assess the metabolic properties of bacterial isolates.
Clinical Applications
This device is commonly used in clinical microbiology laboratories to test for the presence of fermentative bacteria in patient samples. It is particularly useful in identifying pathogens in infections where rapid diagnosis is crucial, such as in cases of sepsis or urinary tract infections. The device is used by laboratory personnel in hospital settings and reference labs, aiding in the diagnosis and management of infectious diseases.
Indications for Use
The Rapid Fermentation Agar RFA is indicated for use in the identification and differentiation of bacteria based on their ability to ferment specific carbohydrates. It is suitable for testing samples from patients suspected of having bacterial infections.
Practical Considerations
The agar is typically supplied in pre-prepared plates or as a dehydrated powder that can be reconstituted. It is compatible with standard laboratory incubators and requires careful handling to avoid contamination. Users should follow standard microbiological practices when using this device.
Frequently Asked Questions
What is Rapid Fermentation Agar RFA used for?
It is used for identifying and differentiating bacteria based on their fermentation capabilities in clinical microbiology laboratories.
What specialties typically use this device?
This device is primarily used by microbiologists and laboratory technicians in clinical microbiology and infectious disease specialties.
What are the FDA-cleared indications?
The device is indicated for identifying bacteria by their fermentation properties, aiding in the diagnosis of bacterial infections.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.