HSA · registration DE0503380Ortho-Clinical VITROS XT Chemistry Products GLU-Ca Slides
- Registration number
- DE0503380
- Model name
- VITROS Chemistry Products Liquid Performance Verifier II; VITROS Chemistry Products Calibrator Kit 1; VITROS Chemistry Products FS Diluent Pack 2; VITROS Chemistry Products FS Diluent Pack 3; VITROS XT Chemistry Products GLU-Ca Slides; VITROS Chemistry Products Performance Verifier I; VITROS Chemistry Products Performance Verifier II; VITROS Chemistry Products 7% BSA; VITROS Chemistry Products Liquid Performance Verifier I
- Model identifier
- 1384007; 1882208; 6801753; 6801754; 6844295; 8067324; 8231474; 8262487; 8466492
- Registration date
- July 18, 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 GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid (CSF) using VITROS XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca) concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms)
- 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.