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

Basic Information

• Brand Name: BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
• Primary DI: 00815381020390
• Version / Model: 423485
• Company Name: BIOFIRE DIAGNOSTICS, LLC
• Labeler DUNS: 079280262
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-03
• Public Version: 1
• Public Version Date: 2024-05-13
• Public Version Status: New
• Public Device Record Key: 1727c63c-a059-4740-a8dc-2cd054b130bc

Device Description

IVD reagent kit containing 30 tests.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OZZ	Bordetella Pertussis Dna Assay System	Microbiology	866.3980	2
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	866.3980	2
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	Microbiology	866.2680	2
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	866.3980	2
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	866.3981	2
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	866.3980	2
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay	Microbiology	866.3980	2
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay	Microbiology	866.3980	2
OZX	Mycoplasma Pneumoniae Dna Assay System	Microbiology	866.3980	2
OZY	Chlamydophila Pneumoniae Dna Assay System	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61527	Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815381020390	GS1

Premarket Submissions

Submission Number	Supplement Number
K232954	000