FDA Browser

Last synced on 30 November 2024 at 11:09 am

ETI-AB-AUK PLUS assay

Page Type: PMA Approval
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: DIASORIN, INC.
Trade Name: DIASORIN ETI-AB-AUK PLUS ASSAY
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 3/30/2001
Days to Decision: 637 days
Decision Code: APPR
FDA Decision: Approval