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Ortho-Clinical VITROS Chemistry Products ALTV Slides - HSA Registration DE0501966

Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products ALTV 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 DE0501966 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on July 29, 2018.

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
DE0501966
Ortho-Clinical VITROS Chemistry Products ALTV Slides
HSA Registration Number: DE0501966
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Product Description

For in vitro diagnostic use only. VITROS Chemistry Products ALTV Slides quantitatively measure alanine aminotransferase (ALT) activity in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0501966
Registration Date
July 29, 2018
Change Notification Approval Date
February 26, 2024
Retention Due Date
July 28, 2025
Product Owner
Short Name
Ortho-Clinical Diagnostics 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 3 VITROS Chemistry Products FS Diluent Pack 2 VITROS Chemistry Products ALTV Slides VITROS Chemistry Products Performance Verifier I VITROS Chemistry Products Performance Verifier II VITROS Chemistry Products 7% BSA
Model Identifier(s)
1290709 6801753 6844288 8067324 8231474 8262487