HSA · registration DE0510529BECKMAN COULTER BECKMAN COULTER DxC 700 AU
- Registration number
- DE0510529
- Model name
- BECKMAN COULTER CHEMISTRY ANALYZER DxC 700 AU
- Model identifier
- B86443
- Registration date
- April 01, 2025
- Source update date
- May 07, 2025
- Risk class
- Class C
- Product owner
- Beckman Coulter Inc
- Registrant / registration holder
- BECKMAN COULTER SINGAPORE PTE. LTD.
The BECKMAN COULTER DxC 700 AU measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) samples, and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, ion selective electrode and homogeneous enzyme immunoassay. This product measures the chemical components in the sample (serum, plasma, urine, and whole blood (HbA1c only)) by mixing (stirring) the sample and reagent.
- Product owner address
- 250 S. Kraemer Blvd, Brea California USA 92821, United States
- Registrant address
- 11 COLLYER QUAY, #05-06C, THE ARCADE, Singapore 049317
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.