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  1. Recently-Approved Devices

LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus, LIAISON QuantiFERON Software - P180047

LIAISON QuantiFERON-TB Gold Plus

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 QuantiFERON-TB Gold Plus
LIAISON Control QuantiFERON-TB Gold Plus
LIAISON QuantiFERON Software

PMA Applicant: DiaSorin, Inc.
Address: 1951 Northwestern Avenue, Stillwater, MN 55082-0285
Approval Date: November 26, 2019
Approval Letter: Approval Order

What is it? The LIAISON QuantiFERON-TB Gold Plus assay is an in vitro diagnostic test intended to determine if a person could be infected with tuberculosis (TB) bacteria. The LIAISON Control QuantiFERON-TB Gold Plus is used as a quality control to ensure the test is working properly. The LIAISON QuantiFERON-TB Software is used to analyze the test results on the LIAISON XL Analyzer.

How does it work? A health care provider collects a patient’s blood sample using the QuantiFERON-TB Gold Plus Blood Collection Tubes and sends them to a laboratory for testing. Because these tubes contain tuberculosis proteins, the patient’s blood will react if a person has been infected with tuberculosis. Patient blood is removed from the collection tubes and mixed with test chemicals using the LIAISON XL Analyzer and evaluated. Laboratory clinicians or the LIAISON QuantiFERON-TB Software can calculate a result.

When is it used? The LIAISON QuantiFERON-TB Gold Plus assay is used when doctors suspect a person may be infected with TB bacteria.

What will it accomplish? Doctors use the test result together with a patient’s medical history, physical examination, X-ray, and other medical evaluations to help diagnose TB infection.

When should it not be used? The LIAISON QuantiFERON-TB Gold Plus assay should not be used as the only test for diagnosis of a TB infection.

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