Cepheid Xpert HIV-1 Qual

Pajjiż: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Disponibbli minn:

SPD SCIENTIFIC PTE LTD

Klassi:

Class D IVD

Manifatturat minn:

Cepheid AB

Żona terapewtika:

Microbiology

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Models: Xpert HIV-1 Qual - GXHIV-QA-CE-10

Data ta 'l-awtorizzazzjoni:

2020-07-01