ACCESS HBsAg Confirmatory

GUDID 15099590806262

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.

Beckman Coulter, Inc.

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590806262
• NIH Device Record Key: b61ebd3d-1c65-4cd9-841c-0985f294f242
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS HBsAg Confirmatory
• Version Model Number: D22914
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590806262 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-16

Devices Manufactured by Beckman Coulter, Inc.

• 15099590806255 - ACCESS HBsAg: 2026-01-26 The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of hepati
• 15099590806262 - ACCESS HBsAg Confirmatory: 2026-01-26The 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.
• 15099590806262 - ACCESS HBsAg Confirmatory: 2026-01-26 The Access HBsAg Confirmatory assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative confir
• 15099590806279 - Access HBsAg CALIBRATOR: 2026-01-26 The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and Access HBsAg Confirmatory assays for the in vitro qual
• 15099590806286 - ACCESS HBsAg QC: 2026-01-26 The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAg Confirmatory assays. The
• 15099590806415 - ACCESS anti-HAV: 2026-01-26 The Access anti-HAV assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection of tot
• 15099590806422 - ACCESS anti-HAV CALIBRATOR: 2026-01-26 The Access anti-HAV Calibrator is intended to calibrate the Access anti-HAV assay for the in vitro qualitative detection of anti
• 15099590806439 - ACCESS anti-HAV QC: 2026-01-26 The Access anti-HAV QC is intended for monitoring system performance of the Access anti-HAV assay. The Access anti-HAV QC is for
• 15099590799717 - MicroScan: 2025-12-25 MicroScan LabPro V5.03 System (US), Electronic