HSA · registration DE0510491DIA.PRO Diagnostic Bioprobes HDV Ab
SingaporeMicrobiologyClass CDIA.PRO Diagnostic Bioprobes S.r.l.
Official record identity
- Registration number
- DE0510491
- Model name
- HDV Ab
- Model identifier
- DAB.CE
- Registration date
- March 21, 2025
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- DIA.PRO Diagnostic Bioprobes S.r.l.
- Registrant / registration holder
- ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Official description
Competitive Enzyme ImmunoAssay (ELISA) for the qualitative determination of antibodies to Hepatitis Delta Virus or HDV in human plasma and sera with a “two-steps” methodology. The kit is used for the follow-up of patients infected by HDV. For “in vitro” diagnostic use only.
Additional source fields
- Product owner address
- Via Giosuè Carducci, 27 - 20099 Sesto San Giovanni (Ml), Italy
- Registrant address
- 6 HARPER ROAD, #03-02, LEONG HUAT BUILDING, Singapore 369674
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.