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 HBSAG REAGENT PACK AND 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: P000044
• Supplement Number: S027
• Date Received: 08/19/2011
• Decision Date: 09/16/2011
• Product Code: LOM
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CONVERSION OF THE IN PROCESS LIMIT FROM A SIGNAL RATIO TO A TEST RESULT.