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U.S. Department of Health and Human Services

Medical Devices

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Devices For Testing The Hepatitis B Virus (HBV)

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.


Manufacturer:  DiaSorin S.r.l.
Address: Via Cresentino, Saluggia (VC) 13040, Italy

What is it?  This is a series of products consisting of six different laboratory tests to detect antigen(s) or antibodies associated with hepatitis B virus (HBV) infection. The table below describes these tests.

DEVICES FOR TESTING THE HEPATITIS B VIRUS (HBV)

PMA# Product Name What Does It Detect?
990038 DiaSorin ETI-MAK-2 PLUS ASSAY HBV surface antigen
990041 DiaSorin ETI-AB-EBK PLUS ASSAY Antibodies to HBV e antigen
990042 DiaSorin ETI-AB-AUK Plus ASSAY Antibodies to HBV surface antigen
990043 DiaSorin ETI-EBK PLUS ASSAY HBV e antigen
990044 DiaSorin ETI-CORE-IGMK PLUS ASSAY IgM antibodies to HBV core antigen
990045 DiaSorin ETI-AB-COREK PLUS ASSAY Total antibodies to HBV core antigen

How does it work?  A sample of the patient’s blood is placed in contact with either HBV antibodies or HBV antigens. (Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV.) If the patient is infected with HBV, antigens and eventually antibodies will be present, and these will cause a chemical reaction to occur when the test is run. The physician will analyze the results of this reaction and determine the status of HBV in the body.

When is it used?  To determine whether a person is infected with the hepatitis B virus and to help determine what stage the disease is in.

What will it accomplish?  The tests help to determine the stage of HBV infection and what treatment may be needed. Depending on the results of these assays, the doctor may recommend vaccination.

When should it not be used?  These tests should be used only when prescribed by a doctor. Also, they should never be used for screening blood donors, because FDA has not approved them for this purpose.

Additional information: Summary of Safety and Effectiveness and labeling will be available at

P990038 DiaSorin ETI-MAK-2 PLUS ASSAY
P990041 DiaSorin ETI-AB-EBK PLUS ASSAY
P990042 DiaSorin ETI-AB-AUK Plus ASSAY
P990043 DiaSorin ETI-EBK PLUS ASSAY
P990044 DiaSorin ETI-CORE-IGMK PLUS ASSAY
P990045 DiaSorin ETI-AB-COREK PLUS ASSAY