Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR
• Generic Name: Test, hepatitis b (b core, be antigen, be antibody, b core igm)
• Applicant: Ortho-Clinical Diagnostics, Inc.; 100 INDIGO CREEK DR.; ROCHESTER, NY 14626-5101
• PMA Number: P000014
• Supplement Number: S023
• Date Received: 02/14/2011
• Decision Date: 03/10/2011
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGE TO MANUFACTURE AND STORE THE ANTIFOAM SOLUTION USED IN VITROS ANTI-HBS CONJUGATE REAGENT.