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Ortho-Clinical VITROS XT Chemistry Products GLU-Ca Slides - HSA Registration DE0503380

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.

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CLASS B IVD
DE0503380
Ortho-Clinical VITROS XT Chemistry Products GLU-Ca Slides
HSA Registration Number: DE0503380
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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)

Device 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 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