Diasorin Eti-Ab-Auk Plus Assay

Approval order statement

APPROVAL FOR THE DIASORIN ETI-AB-AUK PLUS ASSAY. THE DEVICE IS INDICATED FOR: ETI-AB-AUK PLUS IS AN IN VITRO ENZYME IMMUNOASSAY (EIA) INTENDED FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) IN HUMAN ERUM OR PLASMA (EDTA, CITRATE OR HEPARIN). THE ETI-AB-AUK PLUS IS INTENDED FOR MANUAL USE ONLY. THE DETECTION OF ANTI-HBS IS INDICATIVE OF LABORATORY DIAGNOSIS FOR SEROCONVERSION FROM HEPATITIS B VIRUS (HBV) INFECTION. ANTI-HBS IS ALSO USED TO ASSESS LABORATORY DIAGNOSIS OF PAST EXPOSURE TO HEPATITIS B IN POTENTIAL HEPATITIS B VACCINE RECIPIENTS AND TO DETERMINE THE PRESENCE OS AN IMMUNE RESPONSE IN VACCINE RECIPIENTS. THE ANTI-HBS ASSAY'S PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HVB DISEASE OR THERAPY.