Last synced on 6 December 2024 at 11:05 pm

Elecsys HBsAg Immunoassay

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
ROCHE DIAGNOSTICS CORP.
Trade Name
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
Generic Name
Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date
6/1/2001
Days to Decision
820 days
Decision Code
APWD
FDA Decision
Withdrawal after approval