IMMAGE

Basic Information

• Brand Name: IMMAGE
• Primary DI: 15099590221201
• Version / Model: 447600
• Catalog Number: 447600
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 5
• Public Version Date: 2023-08-28
• Public Version Status: Update
• Public Device Record Key: 740d743f-292c-4a9f-a561-7519d5291c32

Device Description

IMMAGE Immunochemistry Systems ALB Albumin Reagent

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DCF	Albumin, Antigen, Antiserum, Control	Immunology	866.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59071	Albumin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590221201	GS1