PMA P790019S011

Device: ABBOTT AXSYM HAVAB-M 2.0
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S011
Product code: LOL
Decision date: 2004-02-02
Classification: Microbiology
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: APPROVAL FOR THE ABBOTT AXSYM HAVAB-M 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AXSYM HAVAB-M 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION IF IGM ANTIBODY TO HEPATITIS A VIRUS (IGM ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR IGM ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS A VIRAL INFECTION.

Current openFDA PMA Record#

Device: ABBOTT AXSYM HAVAB-M 2.0
Applicant: Abbott Laboratories
PMA number: P790019
Supplement: S011
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 2004-02-02
Decision code: APPR
Date received: 2000-06-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ABBOTT AXSYM HAVAB-M 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AXSYM HAVAB-M 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION IF IGM ANTIBODY TO HEPATITIS A VIRUS (IGM ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR IGM ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS A VIRAL INFECTION.