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ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay

Page Type
PMA Approval
PDF
FDA Hosted PDF
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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