AccessGUDID - DEVICE: FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit (00850056728409)

GUDID

Device Identifier (DI) Information

Brand Name: FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
Version or Model: CP0007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CP0007
Company Name: Lumos Diagnostics, Inc.

Primary DI Number: 00850056728409
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081135788 *Terms of Use

Device Description: FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls 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:	No
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?
47869	Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8fd4767c-60f8-4619-9629-aaf7216e78f7
Public Version Date: December 29, 2023
Public Version Number: 1
DI Record Publish Date: December 21, 2023