HSA · registration DE0510543Beckman Coulter Access 2 Immunoassay System Remanufactured
SingaporeImmunologyClass DBeckman Coulter Inc
Official record identity
- Registration number
- DE0510543
- Model name
- Access 2 Access Immunoassay System Remanufactured
- Model identifier
- 386220 (Refurbished)
- Registration date
- April 03, 2025
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Beckman Coulter Inc
- Registrant / registration holder
- BECKMAN COULTER SINGAPORE PTE. LTD.
Official description
The Access 2 system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Additional source fields
- Product owner address
- 250 S. Kraemer Blvd, Brea California USA 92821, United States
- Registrant address
- 11 COLLYER QUAY, #05-06C, THE ARCADE, Singapore 049317
About this record
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.