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Singapore HSA registration DE0510549

Diasorin LIAISON® VZV IgG HT

Singapore flagSingapore·CLASS C IVD·DiaSorin Italia S.p.A.·Registered April 04, 2025
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510549
Registration Date
April 04, 2025
Retention Due Date
April 03, 2026
Product description
The LIAISON® VZV IgG HT assay uses chemiluminescent immunoassay (CLIA) technology for the in vitro quantitative determination of specific IgG antibodies to varicella-zoster virus (VZV) in human serum, lithium and sodium heparin and K2-EDTA plasma. This assay is intended as an aid in the determination of immune status to VZV and as an aid in the diagnosis of infection of varicella-zoster virus in individuals including pregnant women, transplanted and immunocompromised. The test has to be performed on the LIAISON® XL and LIAISON® XS analyzers only.
Product Owner
Name
DiaSorin Italia S.p.A.
Short Name
DiaSorin Italia S.p.A.
Address
Via Crescentino snc, 13040 Saluggia (VC), ITALY
Registrant
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
LIAISON® VZV IgG HT LIAISON® Control VZV IgG HT AP_nu_311850_VZVGHT_12_01.af3 AP_nu_311850_VZVGHT_31_01.af2
Model Identifier(s)
311850 311851 AP_nu_311850_VZVGHT_12_01.af3 AP_nu_311850_VZVGHT_31_01.af2
About this record

Access comprehensive regulatory information for Diasorin LIAISON® VZV IgG HT 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 DE0510549 and owned by DiaSorin Italia S.p.A.. The device was registered on April 04, 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