Cell ID Smart HIV 12 Rapid Diagnostic Test

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Saadav alates:

CELL ID PTE. LTD.

Klass:

Class D IVD

Valmistatud:

Cell ID Pte Ltd

Terapeutiline ala:

Immunology

Näidustused:

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.

Toote kokkuvõte:

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

Loa andmise kuupäev:

2016-10-14