Singapore HSA registration DE0501404
Ortho-Clinical Vitros ECi/ECiQ Immunodiagnostic Systems
Singapore·CLASS D IVD·Ortho-Clinical Diagnostic Inc·Registered March 20, 2018Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0501404
- Registration Date
- March 20, 2018
- Change Notification Approval Date
- November 06, 2024
- Retention Due Date
- March 19, 2026
Product description
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
- Short Name
- Ortho-Clinical Diagnostic Inc
- Address
- 100 Indigo Creek Drive, Rochester, New York, 14626, New York, UNITED STATES
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 ECiQ Immunodiagnostic System VITROS ECi Immunodiagnostic System Refurbished
- Model Identifier(s)
- 1922814 6801059
About this record
Access comprehensive regulatory information for Ortho-Clinical Vitros ECi/ECiQ Immunodiagnostic Systems 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 DE0501404 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on March 20, 2018.
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