Access CEA Diluent

Basic Information

• Brand Name: Access CEA Diluent
• Primary DI: 15099590624828
• Version / Model: 33206
• Catalog Number: 33206
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: c6546811-7615-41d4-ad00-10356c559e92

Device Description

The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilute patient samples containing CEA concentrations greater than the Access CEA Calibrator S5

Device Characteristics

• Single Use: No
• 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: No
• 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
DHX	System, Test, Carcinoembryonic Antigen	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54615	Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590624828	GS1

Premarket Submissions

Submission Number	Supplement Number
K031270	000