ACCESS anti-HBc Total QC

Basic Information

• Brand Name: ACCESS anti-HBc Total QC
• Primary DI: 15099590806316
• Version / Model: D22919
• Catalog Number: D22919
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-30
• Public Version: 1
• Public Version Date: 2026-04-07
• Public Version Status: New
• Public Device Record Key: 24ff01c7-1c4d-417f-8ea0-f1ba0d271101

Device Description

The Access anti-HBc Total QC is intended for monitoring system performance of the Access anti-HBc Total assay. The Access anti-HBc Total QC is for use on the DxI 9000 Access Immunoassay Analyzer.

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: 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
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	866.3173	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41984	Hepatitis B virus core total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus core antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590806316	GS1