ARTG 462947Access HIV AgAb Combo - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
ARTG ID: 462947 · Beckman Coulter Australia Pty Ltd · Beckman Coulter Inc · Class III · Started September 26, 2024
Good Name: Beckman Coulter Australia Pty Ltd - Access HIV AgAb Combo - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 462947
- Start Date
- September 26, 2024
- Effective Date
- September 26, 2024
- Country
- United States of America
- Address
- 250 South Kraemer Boulevard, Brea, CA, 92821
The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and/or HIV-2 in human serum and plasma, using the DxI 9000 Access Immunoassay Analyzer. The Access HIV Ag/Ab combo assay is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 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 HIV Ag/Ab combo assay is for use on the DxI 9000 Access Immunoassay Analyzer only.
Access comprehensive regulatory information for Access HIV AgAb Combo - HIV1/HIV2 antigen/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 462947 and sponsored by Beckman Coulter Australia Pty Ltd, manufactured by Beckman Coulter Inc in United States of America. The device registration started on September 26, 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.