PMA P030024S014

Device: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
Applicant: Ortho-Clinical Diagnostics
PMA number: P030024
Supplement: S014
Product code: LOM
Decision date: 2011-02-28
Classification: Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Approval order statement: APPROVAL FOR A CHANGE IN THE MANUFACTURING SCALE FOR A COMPONENT REAGENT.

Current openFDA PMA Record#

Device: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
Applicant: Ortho-Clinical Diagnostics
PMA number: P030024
Supplement: S014
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-02-28
Decision code: APPR
Date received: 2010-12-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE MANUFACTURING SCALE FOR A COMPONENT REAGENT.