HSA · registration DE0503368Ortho-Clinical VITROS XT Chemistry Products TRIG-CHOL Slides
- Registration number
- DE0503368
- Model name
- 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
- 1662659; 6801753; 6844292; 8067324; 8231474; 8262487
- Registration date
- July 16, 2019
- Source update date
- April 13, 2021
- Risk class
- Class B
- Product owner
- Ortho-Clinical Diagnostic Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
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 address
- 100 Indigo Creek Drive, Rochester, New York, 14626, New York, United States
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.