ARTG 457646ADVIA Centaur CHIV - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
ARTG ID: 457646 · Siemens Healthcare Pty Ltd · Siemens Healthcare Diagnostics Inc · Class III · Started July 30, 2024
Good Name: Siemens Healthcare Pty Ltd - ADVIA Centaur CHIV - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 457646
- Start Date
- July 30, 2024
- Effective Date
- July 30, 2024
- Country
- United States of America
- Address
- 511 Benedict Avenue, Tarrytown, NY, 10591
An in vitro diagnostic immunoassay for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum and plasma (EDTA) using the ADVIA Centaur XP and ADVIA Centaur XPT systems. The assay is intended to be used as an aid in the diagnosis of individuals (children, adolescents, and adults) with human immunodeficiency virus (HIV) infection. The assay is intended for testing serum and plasma specimens to screen donors whose blood or blood products are intended for transfusion or for further manufacture, or to screen donors whose cells, tissues, and organs are intended for transplant. Specimens may be obtained while the donor's heart is still beating, or from cadaveric (non-heart-beating) donors.
Access comprehensive regulatory information for ADVIA Centaur CHIV - 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 457646 and sponsored by Siemens Healthcare Pty Ltd, manufactured by Siemens Healthcare Diagnostics Inc in United States of America. The device registration started on July 30, 2024.
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