HCV ANTIBODY (TOTAL)

Primary DI

06936155804290

Basic UDI-DI Code

B-06936155804290

Reference

ITP01152-TC40

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List A

Status

On The Market

Manufacturer

InTec PRODUCTS, INC.

Rapid Anti-HCV Test is based on immunochromatography, and is used for virus antibody detection in human whole blood, serum or plasma. This test is simple, convenient and visual and gives a result within 20 minutes. Rapid Anti-HCV Test is colloidal gold enhanced rapid immunochromatographic assay for the qualitative detection of antibodies to hepatitis C virus (HCV) 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 RIBA (Recombinant lmmunoblotting Assay) or equivalent. The test is intended for healthcare professionals' use and trained healthcare workers as a tool to diagnose clinical conditions related to infection with Hepatitis C Virus.

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