Singapore HSA registration DE0503874
Ortho-Clinical VITROS XT Chemistry Products ALB-TP Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered November 29, 2019Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD