PMA P040017

Device

ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

Applicant

Bayer Healthcare, Diagnostics Division

PMA number

P040017

Product code

LOL

Decision date

2005-03-07

Classification

Hepatitis A Test (antibody And Igm Antibody)

Generic name

Hepatitis a test (antibody and igm antibody)

Approval order statement

APPROVAL FOR THE ADVIA CENTAUR HAV TOTAL ASSAY AND QUALITY CONTROL MATERIALS. HAV TOTAL ASSAY INDICATION FOR USE: THE ADVIA CENTAUR HAV TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS A VIRUS (ANTI-HAV ) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THIS ANTI-HAV ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION. HAV TOTAL QUALITY CONTROL MATERIALS INDICATION FOR USE: FOR MONITORING THE PERFORMANCE OF THE HAV TOTAL ASSAY ON ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HAV TOTAL QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV TOTAL ASSAY.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040017B.pdf" target="_new">Summary of Safety and Effectiveness</a>