Singapore HSA registration DE0503380
Ortho-Clinical VITROS XT Chemistry Products GLU-Ca Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostic Inc·Registered July 18, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0503380
- Registration Date
- July 18, 2019
- Change Notification Approval Date
- April 13, 2021
- Retention Due Date
- July 17, 2025
Product description
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
- 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 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(s)
- 1384007 1882208 6801753 6801754 6844295 8067324 8231474 8262487 8466492
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS XT Chemistry Products GLU-Ca 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 DE0503380 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on July 18, 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