ARTG 375204Alinity i HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ARTG ID: 375204 · Abbott Australasia Pty Ltd Diagnostic Division · Abbott Ireland Diagnostics Division · Class III · Started September 23, 2021
Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Alinity i HBsAg Next Confirmatory Assay - Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 375204
- Start Date
- September 23, 2021
- Effective Date
- September 23, 2021
- Country
- Ireland
- Address
- Finisklin Business Park, SLIGO
The HBsAg Next Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) used for the confirmation of the presence of Hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heartbeating),that have been collected up to 24 hours after death, by means of specific antibody neutralization on the Alinity i system.
Access comprehensive regulatory information for Alinity i HBsAg Next Confirmatory Assay - 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 registered under ARTG number 375204 and sponsored by Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Ireland Diagnostics Division in Ireland. The device registration started on September 23, 2021.
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