Australia TGA ARTG recordACCESS HBsAg - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Australia TGA ARTG Registered Device · Beckman Coulter Australia Pty Ltd · Beckman Coulter Inc · Class III · Started June 21, 2024
Good Name: Beckman Coulter Australia Pty Ltd - ACCESS HBsAg - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- June 21, 2024
- Effective Date
- June 21, 2024
- Country
- United States of America
- Address
- 250 South Kraemer Boulevard, Brea, CA, 92821
The Access HBsAg assay is intended for the qualitative detection of hepatitis B virus surface antigen (HBsAg) in human serum and plasma as an aid in the diagnosis of hepatitis B virus infection and as a screening test for blood and plasma donors. The Access HBsAg Calibrator is intended to calibrate the Access HBsAg and HBsAg Confirmatory assays for the qualitative detection and confirmation of hepatitis B virus surface antigen (HBsAg) in human serum and plasma. The Access HBsAg QC is intended for monitoring system performance of the Access HBsAg and Access HBsAg Confirmatory assays. The Access HBsAg Confirmatory assay is intended for the qualitative confirmation of hepatitis B virus surface antigen (HBsAg) in human serum and plasma specimens found to be repeatedly reactive in the Access HBsAg assay as an aid in the diagnosis of hepatitis B virus infection and as a screening test for blood and plasma donors.
Access comprehensive regulatory information for ACCESS HBsAg - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Beckman Coulter Inc in United States of America. The device registration started on June 21, 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.