Elecsys HBeAg

Page Type

PMA Approval

PDF

* The FDA doesn't provide PDFs for all submissions.

Applicant

ROCHE DIAGNOSTICS OPERATIONS INC

Trade Name

ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG

Generic Name

Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Decision Date

3/14/2014

Days to Decision

288 days

Decision Code

APPR

FDA Decision

Approval

FDA Browser

Elecsys HBeAg

Page Type: PMA Approval
PDF: PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: ROCHE DIAGNOSTICS OPERATIONS INC
Trade Name: ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 3/14/2014
Days to Decision: 288 days
Decision Code: APPR
FDA Decision: Approval