FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit CP0007

GUDID 00850056728409

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	00850056728409
NIH Device Record Key	8fd4767c-60f8-4619-9629-aaf7216e78f7
Commercial Distribution Status	In Commercial Distribution
Brand Name	FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
Version Model Number	CP0007
Catalog Number	CP0007
Company DUNS	081135788
Company Name	Lumos Diagnostics, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00850056728409 [Primary]

JJY	Multi-Analyte Controls, All Kinds (Assayed)

Steralize Prior To Use	false
Device Is Sterile	false

00850056728102 - FebriDx® Bacterial / Non-Bacterial Point of Care Assay	2023-12-29 FebriDx® Bacterial / Non-Bacterial Point of Care Assay Test Kit, 25 tests
00850056728409 - FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit	2023-12-29FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
00850056728409 - FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit	2023-12-29 FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
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Mark Image Registration \| Serial	Company Trademark Application Date
FEBRIDX 85839245 4837134 Live/Registered	Rapid Pathogen Screening, Inc. 2013-02-02