Singapore HSA registration DE0507608
Ortho-Clinical VITROS Immunodiagnostic Products Anti-HTLV I/II Assay
Singapore·CLASS D IVD·Ortho-Clinical Diagnostics·Registered December 15, 2022Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0507608
- Registration Date
- December 15, 2022
- Retention Due Date
- December 14, 2025
Product description
“For the in vitro qualitative detection of antibodies to human T-cell lymphotropic virus Types I and/or II, (HTLV-I and HTLV-II) in human serum and plasma (heparin, EDTA and citrate) in adults, pregnant women, adolescents and children, using the automated VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The results of the VITROS Anti-HTLV I/II test, in conjunction with other serological evidence and clinical information, may be used as an aid in the clinical diagnosis of HTLV infection. It may also be used as a screening test to prevent transmission of HTLV to recipients of blood, blood components, cells, tissue and organs. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating”.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics
- Address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- VITROS FS Assay Data Disk VITROS Immunodiagnostic Products Anti-HTLV I/II Reagent Pack VITROS Immunodiagnostic Products Anti-HTLV I/II Calibrator VITROS Immunodiagnostic Products Anti-HTLV I/II Controls
- Model Identifier(s)
- 6801876 6900446 6900448 6900449
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Immunodiagnostic Products Anti-HTLV I/II Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507608 and owned by Ortho-Clinical Diagnostics. The device was registered on December 15, 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 D IVD