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ETI-MAK-2 PLUS and HBsAg Confirmatory Test 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 MAK-2 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

FDA Browser

ETI-MAK-2 PLUS and HBsAg Confirmatory Test 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 MAK-2 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