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11th May 2023 Product update: bioMérieux (Clinical Diagnostics)
US FDA CLIA-waiver for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
A Clinical Laboratory Improvement Amendments (CLIA) waiver has been granted to bioMérieux, for the quick and precise BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini with multiplex PCR. This is in addition to the 510(k) clearance obtained in April 2023.
The COVID-19 pandemic has illustrated the need for medical professionals to have quick-acting diagnostic tests on hand as close to the patient as is practical. The second multiplex PCR-based test approved for use on the BIOFIRE® SPOTFIRE® System is the BIOFIRE® SPOTFIRE® R Panel Mini.
In February 2023, this system and its BIOFIRE® SPOTFIRE® Respiratory Panel with 15 targets received FDA clearance and CLIA waivers.
Approximately 15 minutes are needed for the new BIOFIRE® SPOTFIRE® R Panel Mini to identify five of the most prevalent viruses that cause upper respiratory tract infections:
- Influenza A and B,
- Respiratory Syncytial Virus (RSV),
- and Rhinovirus.
Date Published: 11th May 2023
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
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