Augurex

Basic Information

• Brand Name: Augurex
• Primary DI: 00628425360013
• Version / Model: 1.0
• Catalog Number: 90-0000420
• Company Name: Augurex Life Sciences Corp
• Labeler DUNS: 252066324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-23
• Public Version: 1
• Public Version Date: 2024-10-31
• Public Version Status: New
• Public Device Record Key: daff1c35-bf7b-4589-871b-c4fac1ec6aaf

Device Description

14-3-3eta SRM POS M, 10-pack, 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	00628425360013	GS1