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Singapore HSA registration DE0503684

Cepheid Xpert VanA/VanB

Singapore flagSingapore·CLASS C IVD·Cepheid AB·Registered October 02, 2019
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0503684
Registration Date
October 02, 2019
Change Notification Approval Date
May 15, 2025
Retention Due Date
October 01, 2025
Product description
The Cepheid Xpert vanA/vanB Assay, performed on GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed for rapid detection of vancomycin-resistance (vanA/vanB) genes from rectal and perianal swab specimens in patients at risk for intestinal colonization of vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA and vanB genes that can be associated with Vancomycin-Resistant Enterococci (VRE). The Xpert vanA/vanB Assay is intended to aid in the recognition, prevention and control of vancomycin-resistant organism colonization in healthcare settings. The Xpert vanA/vanB Assay is not intended to diagnose VRE nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification of VRE.
Product Owner
Name
Cepheid AB
Short Name
Cepheid AB
Address
Rontgenvagen 5, SE-171 54 Solna, SWEDEN
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 vanA/vanB
Model Identifier(s)
GXVANA/B-CE-10
About this record

Access comprehensive regulatory information for Cepheid Xpert VanA/VanB 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 DE0503684 and owned by Cepheid AB. The device was registered on October 02, 2019.

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