Singapore HSA registration DE0504551
Cepheid Xpert HIV-1 Viral Load
Singapore·CLASS C IVD·Cepheid AB·Registered June 04, 2020Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0504551
- Registration Date
- June 04, 2020
- Change Notification Approval Date
- January 28, 2025
- Retention Due Date
- June 03, 2025
Product description
The Xpert HIV-1 VL assay is an in vitro reverse transcriptase polymerase chain reaction (RT-PCR) assay for the detection and quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals, using the automated GeneXpert Instrument Systems. The assay can quantify HIV-1 RNA over the range of 40 to 10,000,000 copies/mL. The Xpert HIV-1 VL assay is validated for quantification of RNA from HIV-1 Group M (subtypes A, B, C, D, F, G, H, J, K, CRF01_AE, CRF02_AG, and CRF03_AB), Group N, and Group O. The Xpert HIV-1 VL assay 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.The Xpert HIV-1 VL assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection
Product Owner
- Name
- Cepheid AB
- Short Name
- Cepheid AB
- Address
- Rontgenvagen 5, SE-171 54 Solna, SWEDEN
Registrant
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- Xpert HIV-1 Viral Load
- Model Identifier(s)
- GXHIV-VL-CE-10
About this record
Access comprehensive regulatory information for Cepheid Xpert HIV-1 Viral Load 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 DE0504551 and owned by Cepheid AB. The device was registered on June 04, 2020.
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