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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-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT
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 NumberP000044
Supplement NumberS002
Date Received05/29/2001
Decision Date06/18/2001
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  
CHANGE TO THE ACCEPTANCE CRITERIA APPLIED TO THE TEST FOR HUMAN PLASMA USED AS A RAW MATERIAL IN THE FORMULATION OF ASSAY REAGENT, A COMPONENT OF THE VITROS HBSAG REAGENT PACK AND IN THE FORMULATION OF SAMPLE DILUENT, A COMPONENT OF THE VITROS HBASAG CONFIRMATORY KIT.
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