Singapore HSA registration DE0510472
Beckman Coulter Access Unconjugated Estriol
Singapore·CLASS C IVD·Beckman Coulter Inc·Registered March 17, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510472
- Registration Date
- March 17, 2025
- Retention Due Date
- March 16, 2026
Product description
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
- 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)
- Access Unconjugated Estriol Access Unconjugated Estriol Calibrators Estriol Assay Protocol File
- Model Identifier(s)
- C22255 C22256 Estriol Assay Protocol File
About this record
Access comprehensive regulatory information for Beckman Coulter Access Unconjugated Estriol 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 DE0510472 and owned by Beckman Coulter Inc. The device was registered on March 17, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD