ARTG 440850Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
ARTG ID: 440850 · Roche Diagnostics Australia Pty Limited · Roche Diagnostics GmbH · Class III · Started February 13, 2024
Good Name: Roche Diagnostics Australia Pty Limited - Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 440850
- Start Date
- February 13, 2024
- Effective Date
- February 13, 2024
- Country
- Germany
- Address
- Sandhofer Strasse 116, Mannheim, D-68305
Immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma. The assay can be used as an aid for the diagnosis and monitoring of patients with hepatitis B viral infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Access comprehensive regulatory information for Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-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 440850 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Diagnostics GmbH in Germany. The device registration started on February 13, 2024.
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