Singapore HSA registration DE0506579
Cepheid Xpert Carba-R
Singapore·CLASS C IVD·Cepheid·Registered January 19, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0506579
- Registration Date
- January 19, 2022
- Change Notification Approval Date
- May 15, 2025
- Retention Due Date
- January 18, 2026
Product description
The Xpert Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR). The Xpert Carba-R Assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms.
Product Owner
- Name
- Cepheid
- Short Name
- Cepheid
- Address
- 904 Caribbean Drive Sunnyvale, CA 94089, 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 Carba-R Xpert Carba-R
- Model Identifier(s)
- GXCARBARP-CE-10 GXCARBARP-CE-120
About this record
Access comprehensive regulatory information for Cepheid Xpert Carba-R 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 DE0506579 and owned by Cepheid. The device was registered on January 19, 2022.
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