HSA · registration DE0509505Ortho-Clinical VITROS Chemistry Products A1c Slides
- Registration number
- DE0509505
- Model name
- VITROS Chemistry Products A1c Slides; VITROS Chemistry Products Calibrator Kit 33
- Model identifier
- 6844520; 6844521
- Registration date
- July 09, 2024
- Risk class
- Class B
- Product owner
- Ortho-Clinical Diagnostics Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
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 address
- 100 Indigo Creek Drive, Rochester, New York, 14626, United States
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.