Singapore HSA registration DE0510491
DIA.PRO Diagnostic Bioprobes HDV Ab
Singapore·CLASS C IVD·DIA.PRO Diagnostic Bioprobes S.r.l.·Registered March 21, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0510491
- Registration Date
- March 21, 2025
- Retention Due Date
- March 20, 2026
Product 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.
Product Owner
- Short Name
- DIA.PRO Diagnostic Bioprobes S.r.l.
- Address
- Via Giosuè Carducci, 27 - 20099 Sesto San Giovanni (Ml), ITALY
Registrant
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
- Model Name(s)
- HDV Ab
- Model Identifier(s)
- DAB.CE
About this record
Access comprehensive regulatory information for DIA.PRO Diagnostic Bioprobes HDV Ab in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510491 and owned by DIA.PRO Diagnostic Bioprobes S.r.l.. The device was registered on March 21, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD