PMA P780012S008

Device: IMX(R) HAVAB
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S008
Product code: LOL
Decision date: 1998-05-12
Generic name: Hepatitis a test (antibody and igm antibody)
Approval order statement: Approval for the Abbott IMx(R) HAVAB(R). This device is indicated for the qualitative determiantion of total antibody to heaptitis A antigen in human serum or plasma.

Current openFDA PMA Record

Device: IMX(R) HAVAB
Applicant: Abbott Laboratories
PMA number: P780012
Supplement: S008
Product code: LOL
Generic name: Hepatitis a test (antibody and igm antibody)
Decision date: 1998-05-12
Decision code: APPR
Date received: 1998-02-06
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Abbott IMx(R) HAVAB(R). This device is indicated for the qualitative determiantion of total antibody to heaptitis A antigen in human serum or plasma.