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Singapore HSA registration DE0509328

SSI Diagnostica IMMUVIEW® S. pneumoniae and L. pneumophila Urinary Antigen Test

Singapore flagSingapore·CLASS C IVD·SSI Diagnostica A/S·Registered May 30, 2024
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0509328
Registration Date
May 30, 2024
Retention Due Date
May 29, 2026
Product description
The ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further intended to aid in the diagnosis of S. pneumoniae infections by detection of S. pneumoniae antigen in cerebrospinal fluid (CSF). Results from the ImmuView® S. pneumoniae and L. pneumophila Urinary Antigen Test should be interpreted in conjunction with the patient’s clinical evaluation and other diagnostic methods.
Product Owner
Name
SSI Diagnostica A/S
Short Name
SSI Diagnostica A/S
Address
Herredsvejen 2, 3400 HillerØd, DENMARK
Registrant
Name
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
Model Name(s)
ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test
Model Identifier(s)
18351
About this record

Access comprehensive regulatory information for SSI Diagnostica IMMUVIEW® S. pneumoniae and L. pneumophila Urinary Antigen Test 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 DE0509328 and owned by SSI Diagnostica A/S. The device was registered on May 30, 2024.

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