AccessGUDID - DEVICE: BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel (00815381020390)

GUDID

Device Identifier (DI) Information

Brand Name: BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
Version or Model: 423485
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOFIRE DIAGNOSTICS, LLC

Primary DI Number: 00815381020390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079280262 *Terms of Use

Device Description: IVD reagent kit containing 30 tests.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232954	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1727c63c-a059-4740-a8dc-2cd054b130bc
Public Version Date: May 13, 2024
Public Version Number: 1
DI Record Publish Date: May 03, 2024