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Singapore HSA registration DE0013531

Cepheid Xpert SA Nasal Complete

Singapore flagSingapore·CLASS C IVD·Cepheid·Registered August 05, 2013
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
HSA Product Code
Refer to HPR
HS Code
30063030
Registration information
Registration Number
DE0013531
Registration Date
August 05, 2013
Change Notification Approval Date
May 14, 2025
Retention Due Date
August 04, 2025
Product description
The Cepheid® Xpert SA Nasal Complete Assay performed in the GeneXpert® System is a qualitative in vitro diagnostic test designed for rapid detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk for nasal colonization. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert SA Nasal Complete Assay is intended to aid in the prevention and control of MRSA/SA infections in healthcare settings. The Xpert SA Nasal Complete Assay is not intended to diagnose, guide or monitor treatment for MRSA/SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Product Owner
Name
Cepheid
Short Name
Cepheid
Address
904,, Caribbean drive,, Sunnyvale,, CA, UNITED STATES
Registrant
Name
Cepheid Singapore Pte. Ltd.
Address
138 MARKET STREET, CAPITAGREEN, #05-06, SINGAPORE 048946
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
Xpert SA Nasal Complete
Model Identifier(s)
GXSACOMP-10
About this record

Access comprehensive regulatory information for Cepheid Xpert SA Nasal Complete 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 DE0013531 and owned by Cepheid. The device was registered on August 05, 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