Singapore HSA registration DE0510526
BECKMAN COULTER BECKMAN COULTER DxC 700 AU
Singapore·CLASS C IVD·Beckman Coulter Inc·Registered April 01, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0510526
- Registration Date
- April 01, 2025
- Change Notification Approval Date
- May 07, 2025
- Retention Due Date
- March 31, 2026
Product description
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
- Short Name
- Beckman Coulter Inc
- Address
- 250 S. Kraemer Blvd, Brea California USA 92821, UNITED STATES
Registrant
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
- Model Name(s)
- BECKMAN COULTER CHEMISTRY ANALYZER DxC 700 AU
- Model Identifier(s)
- B86446
About this record
Access comprehensive regulatory information for BECKMAN COULTER BECKMAN COULTER DxC 700 AU in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510526 and owned by Beckman Coulter Inc. The device was registered on April 01, 2025.
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.
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