Cell ID Smart HIV 12 Rapid Diagnostic Test

Country: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Доступно од:

CELL ID PTE. LTD.

Класа:

Class D IVD

Произведен од:

Cell ID Pte Ltd

Терапеутска област:

Immunology

Терапеутске индикације:

Smart HIV 1/2 RDT Device - Diagnostic device for Antibody to Human Immunodeficiency Virus (1/2) (Colloidal Gold) is a single use rapid immunoassay, for the qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 and 2 in human serum, plasma or whole blood. This test is intended for use, at point of care settings, as an aid in diagnosis of infection with HIV-1 and HIV-2 virus. Users are the professionals in hospitals and clinics. A non-reactive result does not preclude the possibility of exposure to HIV or infection with HIV. Clinical correlation is indicated with appropriate medical evaluation and possibly additional testing to decide whether a diagnosis of HIV infection is accurate. All positive specimens must be confirmed with Western Blot or other qualified ELISA test systems.

Резиме производа:

Models: Smart HIV 1/2 RDT Device - C-A01, Smart HIV 1/2 RDT Device - C-A01-01, Smart HIV 1/2 RDT Device - C-A01-02, Smart HIV 1/2 RDT Device - C-A01-03

Датум одобрења:

2016-10-14