PMA P780012S009

Device: ABBOTT AXSYM HAVAB 2.0
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S009
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 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT AXSYM HAVAB 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODY TO HEPATITIS A VIRUS (ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR ANTI-HAV 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.

Current openFDA PMA Record#

Device: ABBOTT AXSYM HAVAB 2.0
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S009
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 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ABBOTT AXSYM HAVAB 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF TOTAL ANTIBODY TO HEPATITIS A VIRUS (ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR ANTI-HAV 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.