Cepheid Xpert HIV-1 Qual XC

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SPD SCIENTIFIC PTE LTD

Class:

Class D IVD

Manufactured by:

Cepheid AB

Therapeutic area:

Immunology

Therapeutic indications:

Xpert® HIV-1 Qual XC (Extended Coverage) is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) total nucleic acids, on the automated GeneXpert® System. The test is used to detect HIV-1 in human dried blood spots (DBS) and EDTA capillary or venous whole blood (WB) specimens from individuals suspected of HIV-1 infection. Xpert® HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent and adult populations. Xpert® HIV-1 Qual XC is intended to be used by laboratory professionals, trained health care professionals or other health care workers receiving appropriate training on the use of the device. This test may be used in laboratory or near-patient testing environments. The test is not intended to be used as a blood, organ or tissue donor screening test for HIV-1.

Product summary:

Models: Xpert® HIV-1 Qual XC - GXHIV-QA-XC-CE-10, Xpert® HIV-1 Qual XC Assay Definition File - Xpert® HIV-1 Qual XC Assay Definition File

Authorization date:

2022-12-01