Singapore HSA registration DE0501966
Ortho-Clinical VITROS Chemistry Products ALTV Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered July 29, 2018Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD