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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceVITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantOrtho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester, NY 14626
PMA NumberP090028
Supplement NumberS010
Date Received12/02/2016
Decision Date09/12/2017
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the migration of the VITROS Immunodiagnostic Products HBeAg Reagent Pack, Calibrator, and Controls to two additional systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.
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