AccessGUDID - DEVICE: BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel (00851458005259)

GUDID

Device Identifier (DI) Information

Brand Name: BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel
Version or Model: DFA2-ASY-0006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DFA2-ASY-0006
Company Name: BIOFIRE DEFENSE, LLC

Primary DI Number: 00851458005259
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 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?
61055	Multiple-type tropical 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 associated with febrile infection in tropical areas, in a clinical specimen. Organisms detected may include (but are not limited to) Dengue virus, Chikungunya virus, Salmonella spp, West Nile virus, Plasmodium spp., Rickettsia spp. and/or Leptospirosis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202382	000
K220870	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: 4ce4946c-7539-48a4-9f67-a962a458f317
Public Version Date: March 29, 2023
Public Version Number: 2
DI Record Publish Date: July 16, 2021