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VITROS ECiQ Immunodiagnostic System - SFDA Registration ME0000004466SFDAA00003

Access comprehensive regulatory information for VITROS ECiQ Immunodiagnostic System in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000004466SFDAA00003 and manufactured by Ortho Clinical Diagnostics Inc..

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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General IVD(Others)
ME0000004466SFDAA00003
VITROS ECiQ Immunodiagnostic System
SFDA Registration: ME0000004466SFDAA00003
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Product Information

System used to perform random access batch and STAT assays on human fluid specimens.

Product Use

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
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000004466SFDAA00003
Authorization ID
GHTF-2019-4618
Status
Active
Expire Date
November 13, 2023
Manufacturer
Model Information
Model ID(s)
1922814
Product Accessories

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