HSA · registration DE0503432Ortho-Clinical VITROS XT Chemistry Products TBIL-ALKP Slides
- Registration number
- DE0503432
- Model name
- VITROS Chemistry Products Calibrator Kit 4; VITROS Chemistry Products Calibrator Kit 3; VITROS Chemistry Products FS Diluent Pack 2; VITROS Chemistry Products FS Diluent Pack 3; VITROS XT Chemistry Products TBIL-ALKP Slides; VITROS Chemistry Products Performance Verifier I; VITROS Chemistry Products Performance Verifier II; VITROS Chemistry Products 7% BSA
- Model identifier
- 1204668; 1290709; 6801753; 6801754; 6844296; 8067324; 8231474; 8262487
- Registration date
- August 02, 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 TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder block. The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal 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.