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Cepheid Xpert® C. difficile/Epi - HSA Registration DE0013748

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.

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CLASS C IVD
DE0013748
Cepheid Xpert® C. difficile/Epi
HSA Registration Number: DE0013748
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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).

Device 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 Owner
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