Singapore HSA registration DE0507514
Diasorin LIAISON® Mycoplasma pneumoniae IgM
Singapore·CLASS C IVD·DiaSorin Italia S.p.A.·Registered November 21, 2022Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD