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legionella pneumophilla histology control slides
Sigma Diagnostics
Summary: Legionella Pneumophilla Histology Control Slides are used in pathology labs to ensure accurate histological analysis of tissue samples. They are primarily used by pathologists and laboratory technicians.
FDA Clearance Information
Pathway
510K
Number
K881110 ↗
Decision Date
April 12, 1988
Product Code
LJG
Device Class
Class 1
Evidence
419 studies
The device was cleared through the FDA 510(k) pathway on April 12, 1988, by Sigma Diagnostics. It is classified as a Class 1 device under product code LJG.
What It Is
Legionella Pneumophilla Histology Control Slides are specialized slides used in histological examinations to verify the presence of Legionella pneumophila in tissue samples. These slides serve as a control to ensure that staining and microscopic analysis are performed accurately. They are essential for confirming diagnostic tests and ensuring quality control in laboratory settings.
Clinical Applications
These control slides are commonly used in pathology laboratories during the histological examination of lung tissue samples, particularly when Legionella infection is suspected. They are crucial in the diagnosis of Legionnaires' disease, a severe form of pneumonia. Pathologists and laboratory technicians in hospital and research settings frequently utilize these slides to ensure diagnostic accuracy.
Indications for Use
The slides are indicated for use in the histological analysis of tissue samples where Legionella pneumophila infection is suspected. They help confirm the presence of the bacteria in lung tissue, aiding in the diagnosis of conditions like Legionnaires' disease.
Practical Considerations
These slides are typically compatible with standard histological staining techniques. They should be handled with care to avoid contamination and ensure accurate results. Proper storage and handling are essential to maintain their integrity and effectiveness in diagnostic procedures.
Linked Studies (20)
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Florida public health review
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Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
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RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Legionella Pneumophilla Histology Control Slides used for?
They are used to verify the presence of Legionella pneumophila in tissue samples during histological examinations.
What specialties typically use this device?
Pathology and laboratory medicine specialties commonly use these slides, particularly in hospital and research lab settings.
What are the FDA-cleared indications?
The slides are indicated for use in confirming the presence of Legionella pneumophila in tissue samples, aiding in the diagnosis of infections like Legionnaires' disease.
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.