OnSite HIV 1/2 Ab Plus Combo Rapid Test

Primary DI

00855402007771

Basic UDI-DI Code

B-00855402007771

Reference

R0011C

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List A

Status

On The Market

Manufacturer

CTK Biotech Inc.

The OnSite HIV 1/2 Ab Plus Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection of anti-HIV-1 (including subtype O) and anti-HIV-2 antibodies (IgG, IgM, IgA) in human serum, plasma or whole blood. It is intended to be used by healthcare professionals as an aid in the diagnosis of infection with HIV. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of healthcare providers. Alternative test method(s) should be used to confirm the test result obtained by this device.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).