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Singapore HSA registration DE0504661

Cepheid Xpert HIV-1 Qual

Singapore flagSingapore·CLASS D IVD·Cepheid AB·Registered July 01, 2020
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0504661
Registration Date
July 01, 2020
Change Notification Approval Date
January 28, 2025
Retention Due Date
June 30, 2025
Product description
The Xpert HIV-1 Qual assay, performed on the GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Human Immunodeficiency Virus Type 1 (HIV-1) total nucleic acids on the automated GeneXpert® Systems using human whole blood (WB) and dried blood spot (DBS) specimens from individuals suspected of HIV-1 infection and is validated for specimens across 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 Qual assay is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers. The assay is intended to be used by laboratory professionals or specifically-trained healthcare workers. The assay is not intended to be used as a blood donor screening test for HIV-1.
Product Owner
Name
Cepheid AB
Short Name
Cepheid AB
Address
Rontgenvagen 5, SE-171 54 Solna, SWEDEN
Registrant
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
Xpert HIV-1 Qual
Model Identifier(s)
GXHIV-QA-CE-10
About this record

Access comprehensive regulatory information for Cepheid Xpert HIV-1 Qual in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0504661 and owned by Cepheid AB. The device was registered on July 01, 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 D IVD