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Singapore HSA registration DE0504857

Ortho-Clinical VITROS Immunodiagnostics Product Syphilis TPA Assay

Singapore flagSingapore·CLASS C IVD·Ortho-Clinical Diagnostics·Registered August 24, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0504857
Registration Date
August 24, 2020
Change Notification Approval Date
July 08, 2021
Retention Due Date
August 23, 2025
Product description
For the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP) specific antigens in human serum and plasma (heparin, EDTA and citrate) using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems.The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of recent, past or treated syphilis infection.
Product Owner
Name
Ortho-Clinical Diagnostics
Short Name
Ortho-Clinical Diagnostics
Address
Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
Model Name(s)
VITROS Immunodiagnostic Products Syphilis TPA Reagent Pack VITROS Immunodiagnostic Products Syphilis TPA Calibrators VITROS Immunodiagnostic Products Syphilis TPA Control
Model Identifier(s)
6842803 6842804 6842805
About this record

Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostics Product Syphilis TPA Assay 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 DE0504857 and owned by Ortho-Clinical Diagnostics. The device was registered on August 24, 2020.

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