Multiple infectious organism IVDs

Intended purpose

Randox Laboratories Ltd produce a range of Serology Controls as non assay-specific quality control material intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. These Serology Controls are provided unassayed without target values and are suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer's kit controls provided with the assay.