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HSA · registration DE0504857

Ortho-Clinical VITROS Immunodiagnostics Product Syphilis TPA Assay

SingaporeImmunologyClass COrtho-Clinical Diagnostics
Verified
Official record identity
Registration number
DE0504857
Model name
VITROS Immunodiagnostic Products Syphilis TPA Reagent Pack; VITROS Immunodiagnostic Products Syphilis TPA Calibrators; VITROS Immunodiagnostic Products Syphilis TPA Control
Model identifier
6842803; 6842804; 6842805
Registration date
August 24, 2020
Source update date
July 08, 2021
Classification
Risk class
Class C
Official value: CLASS C
Published category
Immunology
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Published parties
Product owner
Ortho-Clinical Diagnostics
Registrant / registration holder
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Official 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.

Additional source fields
Product owner address
Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
Registrant address
1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.