HSA · registration DE0504647Ortho-Clinical VITROS Chemistry Products HbA1c Reagent Kit
- Registration number
- DE0504647
- Model name
- VITROS Chemistry Products %A1c Performance Verifier I; VITROS Chemistry Products %A1c Performance Verifier II; VITROS Chemistry Products FS Reconstitution Diluent; VITROS Chemistry Products HbA1c Reagent Kit; VITROS Chemistry Products Calibrator Kit 31
- Model identifier
- 6801750; 6801751; 6801874; 6842905; 6842906
- Registration date
- June 30, 2020
- Risk class
- Class B
- Product owner
- Ortho-Clinical Diagnostic Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
For in vitro diagnostic use only. VITROS Chemistry Products HbA1c reagent is used on the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. The test is to be used as an aid in diagnosis of diabetes, 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, New York, 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.