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Ortho-Clinical VITROS XT Chemistry Products TBIL-ALKP Slides - HSA Registration DE0503432

Access comprehensive regulatory information for Ortho-Clinical VITROS XT Chemistry Products TBIL-ALKP 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 DE0503432 and owned by Ortho-Clinical Diagnostic Inc. The device was registered on August 02, 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
DE0503432
Ortho-Clinical VITROS XT Chemistry Products TBIL-ALKP Slides
HSA Registration Number: DE0503432
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Product Description

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

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0503432
Registration Date
August 02, 2019
Change Notification Approval Date
April 13, 2021
Retention Due Date
August 01, 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 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(s)
1204668 1290709 6801753 6801754 6844296 8067324 8231474 8262487