Pure Global

Ortho-Clinical Vitros ECi/ECiQ Immunodiagnostic Systems - HSA Registration DE0501404

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D IVD
DE0501404
Ortho-Clinical Vitros ECi/ECiQ Immunodiagnostic Systems
HSA Registration Number: DE0501404
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

For In Vitro Diagnostic use only. The VITROSยฎ 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.

Device 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 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