Singapore HSA registration DE0502725
Ortho-Clinical VITROS XT Chemistry Products UREA-CREA Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered January 25, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0502725
- Registration Date
- January 25, 2019
- Change Notification Approval Date
- August 22, 2020
- Retention Due Date
- January 24, 2026
Product description
For in vitro diagnostic use only The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea concentration, reported as either urea nitrogen or urea (UREA) in serum, plasma, and urine using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. The CREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures creatinine (CREA) concentration in serum, plasma, and urine using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems.
Product Owner
- Short Name
- Ortho-Clinical Diagnostics Inc
- Address
- 100 Indigo Creek Drive, Rochester, New York, 14626, 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 Chemistry Products Calibrator Kit 1 VITROS Chemistry Products FS Diluent Pack 2 VITROS Chemistry Products FS Diluent Pack 3 VITROS XT Chemistry Products UREA-CREA Slides VITROS Chemistry Products Performance Verifier I VITROS Chemistry Products Performance Verifier II VITROS Chemistry Products 7% BSA
- Model Identifier(s)
- 1882208 6801753 6801754 6844294 8067324 8231474 8262487
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS XT Chemistry Products UREA-CREA Slides in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0502725 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on January 25, 2019.
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 B IVD