HSA · registration DE0510472Beckman Coulter Access Unconjugated Estriol
- Registration number
- DE0510472
- Model name
- Access Unconjugated Estriol; Access Unconjugated Estriol Calibrators; Estriol Assay Protocol File
- Model identifier
- C22255; C22256; Estriol Assay Protocol File
- Registration date
- March 17, 2025
- Risk class
- Class C
- Product owner
- Beckman Coulter Inc
- Registrant / registration holder
- BECKMAN COULTER SINGAPORE PTE. LTD.
The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems. The concentration of unconjugated estriol determined by this kit can be used in conjunction with βhCG, AFP, and Inhibin A concentrations in Trisomy 18 and 21 (Down syndrome) risk assessment. Such an approach has been verified on the basis of multivariate Gaussian distribution analysis.
- 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.