Singapore HSA registration DE0503368
Ortho-Clinical VITROS XT Chemistry Products TRIG-CHOL Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostic Inc·Registered July 16, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0503368
- Registration Date
- July 16, 2019
- Change Notification Approval Date
- April 13, 2021
- Retention Due Date
- July 15, 2025
Product description
The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and the VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and the VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases
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 Chemistry Products Calibrator Kit 2 VITROS Chemistry Products FS Diluent Pack 2 VITROS XT Chemistry Products TRIG-CHOL Slides VITROS Chemistry Products Performance Verifier I VITROS Chemistry Products Performance Verifier II VITROS Chemistry Products 7% BSA
- Model Identifier(s)
- 1662659 6801753 6844292 8067324 8231474 8262487
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS XT Chemistry Products TRIG-CHOL 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 DE0503368 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on July 16, 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