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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 Anti-HBc Reagent Pack and Calibrator
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantOrtho-Clinical Diagnostics
100 Indigo Creek Dr.
Rochester, NY 14626
PMA NumberP030024
Supplement NumberS027
Date Received09/17/2018
Decision Date10/16/2018
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add an additional supplier, and implement an in-house processing step for a critical raw material.
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