ARTG 468025ACCESS anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ARTG ID: 468025 · Beckman Coulter Australia Pty Ltd · Beckman Coulter Inc · Class III · Started November 11, 2024
Good Name: Beckman Coulter Australia Pty Ltd - ACCESS anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 468025
- Start Date
- November 11, 2024
- Effective Date
- November 11, 2024
- Country
- United States of America
- Address
- 250 South Kraemer Boulevard, Brea, CA, 92821
The Access anti-HBc IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of IgM antibodies to hepatitis B virus core antigen (anti-HBc IgM) in human serum and plasma using the DxI 9000 Access Immunoassay Analyzer. The Access anti-HBc IgM assay is intended to be used as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection. The Access anti-HBc IgM assay is for use on the DxI 9000 Access Immunoassay Analyzer only.
Access comprehensive regulatory information for ACCESS anti-HBc IgM - Hepatitis B virus core immunoglobulin M (IgM) 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 468025 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Beckman Coulter Inc in United States of America. The device registration started on November 11, 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.