ACCESS HBsAg Confirmatory
- Primary DI
- 15099590806262
- Brand
- ACCESS HBsAg Confirmatory
- Company
- Beckman Coulter, Inc.
- Model
- D22914
- Device description
- The Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human pediatric (7 through 21 years) and adult serum and serum separator tubes or plasma [lithium heparin, lithium heparin separator tubes, dipotassium (K2) EDTA, tripotassium (K3) EDTA, sodium citrate, acid citrate dextrose (ACD), and citrate phosphate dextrose (CPD)] that have been found to be repeatedly reactive in the Access HBsAg assay using the DxI 9000 Access Immunoassay Analyzer.
- Published
- 2026-01-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 15099590806262 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15099590806262 | 15099590806262 |
GMDN Terms#
| Term | Definition |
|---|---|
| Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen, using a chemiluminescent immunoassay method. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 008254708
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 15099590807696 | UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter) | D30863 | D30863 | 2026-05-19 |
| 15099590806323 | Access anti-HBc IgM | D22920 | D22920 | 2026-05-04 |
| 15099590806330 | Access anti-HBc IgM Calibrator | D22921 | D22921 | 2026-05-04 |
| 15099590806347 | Access anti-HBc IgM QC | D22922 | D22922 | 2026-05-04 |
| 15099590806446 | Access anti-HAV IgM | D25834 | D25834 | 2026-04-23 |
| 15099590806453 | Access anti-HAV IgM Calibrator | D25835 | D25835 | 2026-04-23 |
| 15099590806460 | Access anti-HAV IgM QC | D25836 | D25836 | 2026-04-23 |
| 15099590233501 | Synchron | 472500 | 472500 | 2016-08-24 |
| 15099590786533 | Access BNP II | D06227 | D06227 | 2026-03-30 |
| 15099590806293 | Hepatitis B Virus core Total Antibody | D22917 | D22917 | 2026-03-30 |
| 15099590806309 | ACCESS anti-HBc Total CALIBRATOR | D22918 | D22918 | 2026-03-30 |
| 15099590806316 | ACCESS anti-HBc Total QC | D22919 | D22919 | 2026-03-30 |
| 15099590572822 | Cytomics FC500 | UPS (MPL) | 626554 | 2016-09-23 |
| 15099590572839 | Cytomics FC500 | UPS (CXP) | 626553 | 2016-09-23 |
| 15099590736002 | Access PCT | C53987 | C53987 | 2023-05-05 |
| 15099590806255 | ACCESS HBsAg | D22913 | 2026-01-16 | |
| 15099590806279 | Access HBsAg CALIBRATOR | D22915 | 2026-01-16 | |
| 15099590806286 | ACCESS HBsAg QC | D22916 | 2026-01-16 | |
| 15099590806415 | ACCESS anti-HAV | D25831 | 2026-01-16 | |
| 15099590806422 | ACCESS anti-HAV CALIBRATOR | D25832 | 2026-01-16 |