HSA · registration DE0509913Roche Diagnostics Elecsys® Anti-HEV IgM
SingaporeImmunologyClass CRoche Diagnostics GmbH
Official record identity
- Registration number
- DE0509913
- Model name
- Elecsys® Anti-HEV IgM; Elecsys® Anti-HEV IgM; PreciControl Anti-HEV IgM
- Model identifier
- 09056246190; 09056254190; 09056289190
- Registration date
- October 15, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Roche Diagnostics GmbH
- Registrant / registration holder
- ROCHE DIAGNOSTICS ASIA PACIFIC PTE LTD
Official description
Immunoassay for the in vitro qualitative detection of IgM antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgM assay is used as an aid to detect an acute or recently acquired HEV infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Additional source fields
- Product owner address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
- Registrant address
- 8 Kallang Avenue, #10-01/09, Aperia, Singapore 339509
About this record
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.