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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:

  • SARS-CoV-2,
  • Influenza A and B,
  • Respiratory Syncytial Virus (RSV),
  • and Rhinovirus.

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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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bioMérieux (Clinical Diagnostics)


Marcy L'Etoile


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