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Singapore HSA registration DE0508245

Abbott ARCHITECT HSV-2 IgG

Singapore flagSingapore·CLASS C IVD·Abbott Ireland Diagnostics Division·Registered June 27, 2023
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0508245
Registration Date
June 27, 2023
Retention Due Date
June 26, 2025
Product description
The HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative determination of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma on the ARCHITECT i System. The HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The HSV-2 IgG assay is to be used as an aid in the determination of immune status and as an aid in the diagnosis of HSV infection in individuals including expectant mothers. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. NOTE: The performance of the HSV-2 IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised or immunosuppressed patients.
Product Owner
Name
Abbott Ireland Diagnostics Division
Short Name
Abbott
Address
Finisklin Business Park, Sligo, IRELAND
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
ARCHITECT HSV-2 IgG Calibrator ARCHITECT HSV-2 IgG Controls ARCHITECT HSV-2 IgG ARCHITECT HSV-2 IgG
Model Identifier(s)
04U6001 04U6010 04U6025 04U6035
About this record

Access comprehensive regulatory information for Abbott ARCHITECT HSV-2 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 DE0508245 and owned by Abbott Ireland Diagnostics Division. The device was registered on June 27, 2023.

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