Saudi Arabia SFDA registration ME0000004466SFDAA00003
VITROS ECiQ Immunodiagnostic System
Saudi Arabia·Chemicals·Ortho Clinical Diagnostics Inc.·General IVD(Others)ActiveProduct information
System used to perform random access batch and STAT assays on human fluid specimens.
Product use
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.
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
- Manufacturer Name
- Ortho Clinical Diagnostics Inc.
Model information
- Model ID(s)
- 1922814
Product accessories
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About this record
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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