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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 core, be antigen, be antibody, b core igm)
ApplicantORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101
PMA NumberP030024
Supplement NumberS001
Date Received03/17/2004
Decision Date04/02/2004
Product Code LOM 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REPLACEMENT OF KEY EQUIPMENT USED IN PERFORMING THE COATED WELL TEST PROCEDURE AND THE ACCEPTANCE CRITERIA ASSOCIATED WITH ITS USE. IN ADDITION, THE COATED WELL SAMPLING PLAN, RANDOMIZATION METHODS FOR SAMPLING, AND TEST ERROR CORRECTION METHODS HAVE BEEN IMPROVED TO FURTHER ENSURE BATCH QUALITY AND REDUCTION OF PRODUCTION WASTE FOR THE MANUFACTURE OF THE COATED MICROWELLS.
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