ACCESS HBsAg

GUDID 15099590806255

The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection 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)] using the DxI 9000 Access Immunoassay Analyzer. The Access HBsAg assay is used for the laboratory diagnosis of acute or chronic hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, when used in conjunction with other serological and clinical information. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.

Beckman Coulter, Inc.

Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590806255
• NIH Device Record Key: 375e2a86-6a1c-424c-817b-82e28a33d91e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS HBsAg
• Version Model Number: D22913
• 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	15099590806255 [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: 2026-01-26The Access HBsAg assay is a paramagnetic particle, chemiluminescent immunoassay for the in vitro qualitative detection 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)] using the DxI 9000 Access Immunoassay Analyzer. The Access HBsAg assay is used for the laboratory diagnosis of acute or chronic hepatitis B virus (HBV) infection in individuals with signs and symptoms of hepatitis or at risk for hepatitis B virus infection, when used in conjunction with other serological and clinical information. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.
• 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: 2026-01-26 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