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 Quantitative Reagent Pack and Calibrator |
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 | S036 |
Date Received | 09/22/2020 |
Decision Date | 10/22/2020 |
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 Amendment of the assay specific release for sale limits and customer calibration limits used with Immunodiagnostic Products, VITROS Anti-HBs reagent pack and calibrators. |
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