Source document or public record
FDA 510(k) K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
FDA 510(k) index record K213362. Device: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel. Applicant as listed: Biofire Defense, LLC. Decision date: 2023-03-22.
Source
"device_name": "BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K213362.
Device name: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel. Applicant as listed: Biofire Defense, LLC.
Decision date: 2023-03-22. Decision wording: Substantially Equivalent.
Product code: QVR. Regulation: 21 CFR 866.4000. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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