AccessGUDID - DEVICE: BioFire JI Control Panel M420 (00852720008121)

GUDID

Device Identifier (DI) Information

Brand Name: BioFire JI Control Panel M420
Version or Model: v.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M420
Company Name: Mmqci

Primary DI Number: 00852720008121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 172874245 *Terms of Use

Device Description: External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.

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):	No
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?
48114	Escherichia coli nucleic acid IVD, control	A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of nucleic acid from Escherichia coli (E. coli) bacteria in a clinical specimen.	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 [?]
K203680	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 09b3931e-a647-452f-9594-be82efecc3cd
Public Version Date: November 22, 2022
Public Version Number: 1
DI Record Publish Date: November 14, 2022