A810 Negative Control

Primary DI

00816784020246

Basic UDI-DI Code

B-00816784020246

Reference

2010-0020

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

LGC Clinical Diagnostics, Inc.

ACCURUN® 810 Multi-Marker Negative Control has been formulated for use with in vitro diagnostic test kits for the qualitative determination of Hepatitis B Surface Antigen (HBsAg), Hepatitis B e Antigen (HBeAg), Syphilis RPR, and antibodies to Hepatitis B Surface Antigen (HBs), Hepatitis B Core Antigen (HBc and HBc IgM), Hepatitis B e Antigen (HBe), Hepatitis C Virus (HCV), Hepatitis A Virus (HAV and HAV IgM), Cytomegalovirus (CMV), Treponema pallidum (Syphilis ATA), Borrelia burgdorferi (Lyme IgG and Lyme IgM), HIV 1 and 2, and HTLV I and II

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).