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Singapore HSA registration DE0503833

Ortho-Clinical VITROS XT Chemistry Products ALTV-AST Slides

Singapore flagSingapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered November 20, 2019
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0503833
Registration Date
November 20, 2019
Change Notification Approval Date
April 13, 2021
Retention Due Date
November 19, 2025
Product description
The ALTV test within the VITROS XT Chemistry Products ALTV-AST Slides quantitatively measures alanine aminotransferase (ALT) activity in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS 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. The AST test within the VITROS XT Chemistry Products ALTV-AST Slides quantitatively measures aspartate aminotransferase (AST) activity in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Product Owner
Name
Ortho-Clinical Diagnostics Inc
Short Name
Ortho-Clinical Diagnostics Inc
Address
100 Indigo Creek Drive, Rochester, New York, 14626, UNITED STATES
Registrant
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
Model Name(s)
VITROS Chemistry Products Calibrator Kit 3 VITROS XT Chemistry Products ALTV-AST Slides VITROS Chemistry Products Performance Verifier I VITROS Chemistry Products Performance Verifier II
Model Identifier(s)
1290709 6844291 8067324 8231474
About this record

Access comprehensive regulatory information for Ortho-Clinical VITROS XT Chemistry Products ALTV-AST 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 DE0503833 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on November 20, 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