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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc
PMA Applicant: DiaSorin Inc.
Address: 1951 Northwestern Avenue, Stillwater, MN 55082-0285
Approval Date: January 2, 2020
Approval Letter: Approval Order

This test is used with the LIAISON XL analyzer which runs the assay and analyzes the results.

The LIAISON XL MUREX Control Anti-HBc is used as a quality control to ensure that the test is working properly.

How does it work? A sample of a patient's blood is sent to a clinical laboratory. At the laboratory, the blood is inserted into the LIAISON XL analyzer where it is mixed with the test chemicals. If there are HBV antibodies in the blood sample, a light signal is produced and measured by the LIAISON XL analyzer.

When is it used? The LIAISON XL MUREX Anti-HBc test is used when doctors suspect a person may be infected with the hepatitis B virus.

What will it accomplish? Doctors use the test result together with a patient's medical history and other blood tests to help diagnose an HBV infection in adult and pediatric patients with signs and symptoms of hepatitis or in persons at risk for hepatitis B infection.

When should it not be used? The LIAISON XL MUREX Anti-HBc test should not be used as the only test for diagnosis of an HBV infection or to determine the stage of infection.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data
• Labeling
• PMA Database Entry