HSA · registration DE0507608Ortho-Clinical VITROS Immunodiagnostic Products Anti-HTLV I/II Assay
- Registration number
- DE0507608
- Model name
- 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
- 6801876; 6900446; 6900448; 6900449
- Registration date
- December 15, 2022
- Risk class
- Class D
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
“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 address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
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.