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Ortho-Clinical VITROS XT Chemistry Products ALB-TP Slides - HSA Registration DE0503874

Access comprehensive regulatory information for Ortho-Clinical VITROS XT Chemistry Products ALB-TP 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 DE0503874 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on November 29, 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
DE0503874
Ortho-Clinical VITROS XT Chemistry Products ALB-TP Slides
HSA Registration Number: DE0503874
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Product Description

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only. The TP test within VITROS XT Chemistry Products ALB-TP Slides quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0503874
Registration Date
November 29, 2019
Change Notification Approval Date
April 26, 2021
Retention Due Date
November 28, 2025
Product Owner
Short Name
Ortho-Clinical Diagnostics Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, 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 Calibrator Kit 4 VITROS XT Chemistry Products ALB-TP Slides VITROS Chemistry Products Performance Verifier I VITROS Chemistry Products Performance Verifier II
Model Identifier(s)
1204668 6844293 8067324 8231474