PMA P030024S016

Device: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
Applicant: Ortho-Clinical Diagnostics
PMA number: P030024
Supplement: S016
Product code: LOM
Decision date: 2011-09-27
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 SCALING UP OF A CONJUGATE MANUFACTURING PROCESS FROM 10MG TO 96MG.

Current openFDA PMA Record#

Device: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
Applicant: Ortho-Clinical Diagnostics
PMA number: P030024
Supplement: S016
Product code: LOM
Generic name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Decision date: 2011-09-27
Decision code: APPR
Date received: 2011-05-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR SCALING UP OF A CONJUGATE MANUFACTURING PROCESS FROM 10MG TO 96MG.