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DIA.PRO Diagnostic Bioprobes HDV Ab - HSA Registration DE0510491

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.

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CLASS C IVD
DE0510491
DIA.PRO Diagnostic Bioprobes HDV Ab
HSA Registration Number: DE0510491
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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 โ€œtwo-stepsโ€ methodology. The kit is used for the follow-up of patients infected by HDV. For โ€œin vitroโ€ diagnostic use only.

Device 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 Owner
Short Name
DIA.PRO Diagnostic Bioprobes S.r.l.
Address
Via Giosuรจ 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