HSA · registration DE0501404Ortho-Clinical Vitros ECi/ECiQ Immunodiagnostic Systems
- Registration number
- DE0501404
- Model name
- VITROS ECiQ Immunodiagnostic System; VITROS ECi Immunodiagnostic System Refurbished
- Model identifier
- 1922814; 6801059
- Registration date
- March 20, 2018
- Source update date
- June 03, 2022
- Risk class
- Class D
- Product owner
- Ortho-Clinical Diagnostic Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
For In Vitro Diagnostic use only. The VITROS® ECi/ECiQ Immunodiagnostic System perform random access, batch, and STAT immunodiagnostic assays on human fluid specimens. The system uses chemiluminescence detection technology to provide accurate and reliable results for heterogeneous assays. All reactions for a single quantitative, semi-quantitative, and qualitative measurement take place within a coated well.
- Product owner address
- 100 Indigo Creek Drive, Rochester, New York, 14626, New York, United States
- 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.