HSA · registration DE0509087Ortho-Clinical VITROS Immunodiagnostic Products IL6 Assay
SingaporeImmunologyClass BOrtho-Clinical Diagnostics
Official record identity
- Registration number
- DE0509087
- Model name
- VITROS Immunodiagnostic Products IL-6 Reagent Pack; VITROS Immunodiagnostic Products IL-6 Calibrators; VITROS Immunodiagnostic Products IL-6 Controls
- Model identifier
- 6199971; 6199972; 6199973
- Registration date
- March 21, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Official description
VITROS Immunodiagnostic Products IL-6 reagent pack quantitatively measures interleukin-6 in human serum and plasma using the automated VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. Interleukin-6 measurements are useful in the detection and evaluation of inflammatory disease.
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.