VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Page Type

PMA Approval

PDF

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

Applicant

Ortho-Clinical Diagnostics, Inc.

Trade Name

VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS

Generic Name

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

Decision Date

9/29/2000

Days to Decision

211 days

Decision Code

APPR

FDA Decision

Approval

FDA Browser

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator

Page Type: PMA Approval
PDF: PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant: Ortho-Clinical Diagnostics, Inc.
Trade Name: VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS
Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
Decision Date: 9/29/2000
Days to Decision: 211 days
Decision Code: APPR
FDA Decision: Approval