ARTG 468190

Access anti-HBc Total - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

ARTG ID: 468190 · Beckman Coulter Australia Pty Ltd · Beckman Coulter Inc · Class III · Started November 12, 2024

Good Name: Beckman Coulter Australia Pty Ltd - Access anti-HBc Total - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

Device classification

Risk Class: Class III
Product Type: IVD
ARTG Category: IVD

Registration information

ARTG ID: 468190
Start Date: November 12, 2024
Effective Date: November 12, 2024

Sponsor

Name: Beckman Coulter Australia Pty Ltd

Manufacturer

Name: Beckman Coulter Inc
Country: United States of America
Address: 250 South Kraemer Boulevard, Brea, CA, 92821

Intended purpose

The Access anti-HBc Total assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies against the hepatitis B virus core antigen (anti-HBc) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc Total assay is intended to be used as an aid in the diagnosis of hepatitis B virus (HBV) infection,and as a screening test for blood and plasma donors. The assay is not intended for the testing or screening of pooled specimens. The Access anti-HBc Total assay is for use on the DxI 9000 Access Immunoassay Analyzer only.

About this record

Access comprehensive regulatory information for Access anti-HBc Total - Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 468190 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Beckman Coulter Inc in United States of America. The device registration started on November 12, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.