AccessGUDID - DEVICE: BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane (00851458005280)

GUDID

Device Identifier (DI) Information

Brand Name: BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane
Version or Model: DFA2-ASY-0019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DFA2-ASY-0019
Company Name: BIOFIRE DEFENSE, LLC

Primary DI Number: 00851458005280
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556915205 *Terms of Use

Device Description: BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit

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?
66859	Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QVR	Multiplex Nucleic Acid Detection System For Biothreat Agents
QMV	Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213362	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: 102fbd63-1162-478b-84a6-e21e010573c4
Public Version Date: September 08, 2023
Public Version Number: 1
DI Record Publish Date: August 31, 2023