Singapore HSA registration DE0501509
Ortho-Clinical VITROS Integrated System
Singapore·CLASS D IVD·Ortho-Clinical Diagnostic Inc·Registered April 12, 2018Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0501509
- Registration Date
- April 12, 2018
- Change Notification Approval Date
- November 06, 2024
- Retention Due Date
- April 11, 2026
Product description
For in vitro diagnostic use only. The VITROS Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
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 5600 Integrated System VITROS 5600 Integrated System Refurbished Vitros XT 7600 Integrated System
- Model Identifier(s)
- 6802413 6802915 6844461
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Integrated System 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 DE0501509 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on April 12, 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