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U.S. Department of Health and Human Services

Medical Devices

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Abbott AxSYM® Antibody to Hepatitis C Virus - P970027

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.


Product Name: Abbott AxSYM® Antibody to Hepatitis C Virus
Manufacturer: 
Abbott Laboratories, Inc.
Address: 100 Abbott Park Road, Abbott Park, Illinois 
Approval Date: 
February 5, 2004
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf/p970027a.pdf

What is it? The AxSYM® Antibody to Hepatitis C Virus (Anti-HCV) is a lab test used to help diagnose patients that may be infected with the hepatitis C virus (HCV). This test detects antibodies associated with HCV. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HCV.

The AxSYM® Anti-HCV tests a sample of the liquid part of a patient’s blood (serum) and is analyzed by the AxSYM® System.

When is it used? The AxSYM® Anti-HCV is used along with other lab tests in patients who:

  • Are in an at risk population for HCV, including:
  • HIV patients,
  • hemodialysis patients,
  • renal transplant patients,
  • hemophiliac patients,
  • alcoholic liver disease patients, and
  • inmates of correctional institutions.
  • Exhibit symptoms of HCV, such as:
  • fatigue,
  • stomach pain or nausea,
  • diarrhea,
  • fever,
  • loss of appetite, or
  • yellowish eyes and skin.

What will it accomplish? Results from the AxSYM® Anti-HCV will help a doctor diagnose patients with an HCV infection. Positive results from the AxSYM® Anti-HCV should be followed up with additional tests to confirm past or resolved hepatitis infections from active HCV infections.

When should it not be used? AxSYM® Anti-HCV is not intended for use in screening blood, plasma or tissue donors because it has not proven effective for this use.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p970027