Singapore HSA registration DE0508194
Cepheid Xpert Xpress SARS-CoV-2
Singapore·CLASS D IVD·Cepheid·Registered June 14, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0508194
- Registration Date
- June 14, 2023
- Change Notification Approval Date
- March 24, 2025
- Retention Due Date
- June 13, 2025
Product description
The Xpert Xpress SARS-CoV-2 test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab and nasal swab collected from individuals who are suspected of COVID-19 infection.
Product Owner
- Name
- Cepheid
- Short Name
- Cepheid
- Address
- 904 Caribbean Drive Sunnyvale, CA 94089, UNITED STATES
Registrant
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- Assay Definition File (ADF) Xpert® Xpress SARS-CoV-2
- Model Identifier(s)
- Assay Definition File (ADF) XPRSARS-COV2-10
About this record
Access comprehensive regulatory information for Cepheid Xpert Xpress SARS-CoV-2 in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0508194 and owned by Cepheid. The device was registered on June 14, 2023.
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 D IVD