PMA P790025S006

Device: ABBOTT HBE (RDNA) EIA
Applicant: Abbott Laboratories
PMA number: P790025
Supplement: S006
Product code: LOM
Decision date: 1996-05-17
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL TO MODIFY THE PRODUCT LABELING TO ENHANCE THE SAFETY IN THE USE OF THE ABBOTT HBE (RDNA) EIA. THE LIMITATIONS SECTION WILL BE MODIFIED TOSTATE THAT "SAMPLES CONTAINING RHEUMATOID FACTOR AMY DEMONSTRATE FALSELY ELEVATED VALUES IN THE HBEAG ASSAY," AND THE INTERPRETATION OF RESULTS SECTION WILL BE MODIFIED TOSTATE THAT "IT IS RECOMMENDED THAT PATIENTS BE SCREENED FOR THE PRESENCE OF HBSAG PRIOR TO BEING EVALUATED FOR THE PRESENCE OF HBEAG."

Current openFDA PMA Record

Device: ABBOTT HBE (RDNA) EIA
Applicant: Abbott Laboratories
PMA number: P790025
Supplement: S006
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 1996-05-17
Decision code: APPR
Date received: 1994-12-02
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE PRODUCT LABELING TO ENHANCE THE SAFETY IN THE USE OF THE ABBOTT HBE (RDNA) EIA. THE LIMITATIONS SECTION WILL BE MODIFIED TOSTATE THAT "SAMPLES CONTAINING RHEUMATOID FACTOR AMY DEMONSTRATE FALSELY ELEVATED VALUES IN THE HBEAG ASSAY," AND THE INTERPRETATION OF RESULTS SECTION WILL BE MODIFIED TOSTATE THAT "IT IS RECOMMENDED THAT PATIENTS BE SCREENED FOR THE PRESENCE OF HBSAG PRIOR TO BEING EVALUATED FOR THE PRESENCE OF HBEAG."