Singapore HSA registration DE0510040
Cepheid Xpert® HIV-1 Viral Load XC
Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510040
- Registration Date
- November 13, 2024
- Change Notification Approval Date
- May 15, 2025
- Retention Due Date
- November 12, 2025
Product description
Xpert® HIV-1 Viral Load XC (Extended Coverage) is an in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA in human EDTA plasma using the automated GeneXpert® System. It is intended for use as an aid in clinical management of patients infected with HIV-1. Xpert® HIV-1 Viral Load XC is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels from HIV-1 infected individuals. Xpert® HIV-1 Viral Load XC is intended to be performed by trained professional users or trained healthcare workers in laboratory or near-patient testing environments. Xpert® HIV-1 Viral Load XC is not intended to be used as a donor screening test for HIV-1 infection.
Product Owner
- Name
- Cepheid AB
- Short Name
- Cepheid AB
- Address
- Röntgenvägen 5, SE-171 54 Solna, SWEDEN
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® HIV-1 Viral Load XC Xpert® HIV-1 Viral Load XC Assay Definition File
- Model Identifier(s)
- GXHIV-VL-XC-CE-10 Xpert® HIV-1 Viral Load XC Assay Definition File
About this record
Access comprehensive regulatory information for Cepheid Xpert® HIV-1 Viral Load XC 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 DE0510040 and owned by Cepheid AB. The device was registered on November 13, 2024.
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