HSA · registration DE0510553Roche Diagnostics Elecsys Anti-HBs III
- Registration number
- DE0510553
- Model name
- Elecsys Anti-HBs III; Elecsys Anti-HBs III; PreciControl Anti-HBs
- Model identifier
- 09810471190; 09810501190; 11876317122
- Registration date
- April 04, 2025
- Risk class
- Class D
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
Immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma. The assay, also in conjunction with other relevant laboratory results and clinical information, may be used ▪ as an aid in the determination of an individual’s immune status to hepatitis B virus (HBV), ▪ within the scope of hepatitis B vaccination to assess the necessity and success of vaccination, ▪ as a supplemental test to prevent transmission of HBV to recipients of blood, blood components, cells, tissue, and organs, and ▪ as an aid in monitoring the course of disease following HBV infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
- Product owner address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- Registrant address
- 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.