AccessGUDID - DEVICE: BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini (00815381020727)

GUDID

Device Identifier (DI) Information

Brand Name: BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini
Version or Model: 424537
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOFIRE DIAGNOSTICS, LLC

Primary DI Number: 00815381020727
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:	Yes
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
NSU	Instrumentation For Clinical Multiplex Test Systems
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay
OCC	Respiratory Virus Panel Nucleic Acid Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241194	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: 436893db-15ac-46bd-b5b5-151908891765
Public Version Date: August 05, 2024
Public Version Number: 1
DI Record Publish Date: July 26, 2024