ABBOTT HBE (RDNA) EIA
FDA premarket approval P790025/S006 · decided 1996-05-17
Approval details
- PMA number
- P790025
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT HBE (RDNA) EIA
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 1994-12-02
- Decision date
- 1996-05-17
- Days to decision
- 532 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- 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."
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