HIV MULTIPLE ANTIBODY

Primary DI

06936155804320

Basic UDI-DI Code

B-06936155804320

Reference

ITP02152-TC25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List A

Status

No Longer On The Market

Manufacturer

InTec PRODUCTS, INC.

Human immunodeficiency virus is the pathogen of Acquired Immunodeficiency Syndrome (AIDS)1-2.The ONE STEP Anti-HIV (1&2) Test is a simple, visual qualitative test that detects antibodies in human whole blood, serum or plasma.This test is simple, convenient and gives a result within 20 minutes. The ONE STEP Anti-HIV (1&2) Test is a colloidal gold enhanced, rapidmmunochromatographic assay for qualitative detection of antibodies to HumanImmunodeficiency Virus (HIV) in human whole blood, serum or plasma. This test is a rapid test used as an aid for diagnosis and all positive results must be confirmed using an appropriate test such as immunoblot assay or equivalent. Thistest is intended for healthcare professionals and trained healthcare workers use.

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