PMA P040018

Device

ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Applicant

Bayer Healthcare, LLC

PMA number

P040018

Product code

LOL

Decision date

2004-12-22

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 IGM. HAV IGM READYPACK REAGENTS: THIS DEVICE IS INDICATED FOR USE FOR THE ADVIA CENTAUR HAV IGM ASSAY AND IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IGM RESPONSE TO THE HEPATITIS A VIRUS (HAV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THE ASSAY IS INTENDED FOR USE AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT INFECTION (USUALLY 6 MONTHS OR LESS) WITH HEPATITIS A VIRUS. HAV IGM QUALITY CONTROL MATERIALS: THE CONTROLS ARE INDICATED FOR IN VITRO DIAGNOSTIC USE IN MONITORING THE PERFORMANCE OF THE HAV IGM ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HAV IGM QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER ANTI-HAV IGM ASSAYS.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040018B.pdf" target="_new">Summary of Safety and Effectiveness</a>