Singapore HSA registration DE0509505
Ortho-Clinical VITROS Chemistry Products A1c Slides
Singapore·CLASS B IVD·Ortho-Clinical Diagnostics Inc·Registered July 09, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509505
- Registration Date
- July 09, 2024
- Retention Due Date
- July 08, 2025
Product description
For in vitro diagnostic and laboratory professional use. VITROS Chemistry Products A1c Slides quantitatively measure percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood using the automated VITROS 4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.HbA1c measurements are used as an aid in diagnosis of diabetes mellitus, as an aid in identifying patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
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 A1c Slides VITROS Chemistry Products Calibrator Kit 33
- Model Identifier(s)
- 6844520 6844521
About this record
Access comprehensive regulatory information for Ortho-Clinical VITROS Chemistry Products A1c 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 DE0509505 and owned by Ortho-Clinical Diagnostics Inc. The device was registered on July 09, 2024.
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