Augurex Life Sciences

Basic Information

• Brand Name: Augurex Life Sciences
• Primary DI: 06284510990431
• Version / Model: 90-0021
• Catalog Number: 90-0021
• Company Name: Cedarlane Corporation
• Labeler DUNS: 243928822
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 7655b0c7-4b0d-4ba7-b5b0-ddb15b8bdff7

Device Description

48F10 Anti-Human 14-3-3eta mAb-HRP, Conc ASR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53966	Protein 14-3-3 IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of protein 14-3-3 in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06284510990431	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Unit (depending on QTY ordered)

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -80 – -80 Degrees Celsius