Pure Global

DiaSorin LIAISON® Mycoplasma pneumoniae IgG - HSA Registration DE0507513

Access comprehensive regulatory information for DiaSorin LIAISON® Mycoplasma pneumoniae IgG 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 DE0507513 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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0507513
DiaSorin LIAISON® Mycoplasma pneumoniae IgG
HSA Registration Number: DE0507513
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The LIAISON® Mycoplasma pneumoniae IgG assay uses chemiluminescence immunoassay (CLIA) technology for the semi-quantitative determination of specific IgG 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
DE0507513
Registration Date
November 21, 2022
Change Notification Approval Date
April 04, 2025
Retention Due Date
November 20, 2025
Product Owner
Short Name
DiaSorin Italia S.p.A.
Address
Via Crescentino, snc, 13040 Saluggia (VC) Italy, 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 IgG LIAISON Control Mycoplasma pneumoniae IgG
Model Identifier(s)
317020 317021