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Diasorin LIAISON® Mycoplasma pneumoniae IgM - HSA Registration DE0507514

Access comprehensive regulatory information for Diasorin LIAISON® Mycoplasma pneumoniae IgM 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 DE0507514 and owned by DiaSorin Italia S.p.A.. The device was registered on November 21, 2022.

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
DE0507514
Diasorin LIAISON® Mycoplasma pneumoniae IgM
HSA Registration Number: DE0507514
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Product Description

The LIAISON® Mycoplasma pneumoniae IgM assay uses chemiluminescence immunoassay (CLIA) technology for the qualitative determination of specific IgM antibodies to Mycoplasma pneumoniae in human serum samples. The test has to be performed on the LIAISON® Analyzer family.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0507514
Registration Date
November 21, 2022
Change Notification Approval Date
November 03, 2023
Retention Due Date
November 20, 2025
Product Owner
Short Name
DiaSorin Italia S.p.A.
Address
Via Crescentino snc, 13040 Saluggia (VC), ITALY
Registrant
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model Information
Model Name(s)
LIAISON Mycoplasma pneumoniae IgM LIAISON Control Mycoplasma pneumoniae IgM
Model Identifier(s)
317030 317031