Singapore HSA registration DE0013748
Cepheid Xpert® C. difficile/Epi
Singapore·CLASS C IVD·Cepheid·Registered September 02, 2013Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0013748
- Registration Date
- September 02, 2013
- Change Notification Approval Date
- May 14, 2025
- Retention Due Date
- September 01, 2025
Product description
The Cepheid Xpert® C. difficile/Epi Assay is a qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
Product Owner
- Name
- Cepheid
- Short Name
- Cepheid
- Address
- 904,, Caribbean drive,, Sunnyvale,, CA, UNITED STATES
Registrant
- Address
- 138 MARKET STREET, CAPITAGREEN, #05-06, SINGAPORE 048946
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- Xpert C.difficile/Epi Xpert C.difficile/Epi
- Model Identifier(s)
- GXCDIFF/EPI-10 GXCDIFF/EPI-120
About this record
Access comprehensive regulatory information for Cepheid Xpert® C. difficile/Epi 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 DE0013748 and owned by Cepheid. The device was registered on September 02, 2013.
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