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. |
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Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS |
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 | P000014 |
Supplement Number | S007 |
Date Received | 05/05/2004 |
Decision Date | 05/14/2004 |
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 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 REDUCE PRODUCTION WASTE. THE COATED WELL TEST PROCEDURE IS USED TO VERIFY AN ACCEPTABLE LEVEL OF WELL-TO-WELL PRECISION AND OUTLIER-LEVEL INCIDENCE IN THE COATED WELLS MANUFACTURED FOR THE VITROS ANTI-HBS ASSAY. |
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