Device
The Access anti-HBc IgM QC is intended for monitoring system performance of the Access anti-HBc IgM assay. The
Manufacturer
Beckman Coulter, Inc.
Beckman Coulter, Inc.
Model: D22922
Catalog: D22922
DI: 15099590806347
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
The Access anti-HBc IgM QC is intended for monitoring system performance of the Access anti-HBc IgM assay. The
Access anti-HBc IgM QC is for use on the DxI 9000 Access Immunoassay Analyzer.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d2432a62-7468-483b-82d9-da64257e3c74
Distribution Status:
In Commercial Distribution
DUNS Number:
008254708
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
15099590806347
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41982
Name: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Definition:
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen.
FDA Product Codes
SEI
Qualitative And Quantitative Hepatitis B Virus Antibody Assays