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FDA 510(k)

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

K-Number: K232954 · 2024-03-26

ApplicantBiofire Diagnostics, LLC
Decision Date2024-03-26
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2024-03-26 under approval number K232954. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel?

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is a medical device that received FDA 510(k) clearance on 2024-03-26. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K232954.

When was BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel approved by the FDA?

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel received FDA 510(k) clearance on 2024-03-26, under approval number K232954.

What company makes BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel?

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel?

The FDA product code for BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel is QOF.

Related Clinical Trials

NCT00448981 Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial COMPLETED NCT07522346 deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants NOT_YET_RECRUITING NCT07513519 Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial RECRUITING NCT07041671 Evaluation Viral RNA and Virus Infectivity in Exhaled Air Before and After Use of One Dose With ColdZyme Mouth Spray RECRUITING

Related PubMed Literature

PMID: 35290135 Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery (2022)

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Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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