A1 Series 4400

Primary DI

00816784020055

Basic UDI-DI Code

B-00816784020055

Reference

2000-0010

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

LGC Clinical Diagnostics, Inc.

ACCURUN 1 controls are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. ACCURUN® 1 Multi-Marker Positive Controls have been formulated for use with in vitro diagnostic test kits for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T -Lymphotropic Virus Types I and II (HTLV I and II), antibodies to Hepatitis B Core Antigen (HBcAg), antibodies to Hepatitis C Virus (HCV), antibodies to Cytomegalovirus (CMV), and Hepatitis B Surface Antigen (HBsAg).

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