| 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 |
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| Generic Name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
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| Regulation Number | 866.3172 |
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| Applicant | Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester, NY 14626 |
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| PMA Number | P000014 |
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| Supplement Number | S034 |
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| Date Received | 10/16/2018 |
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| Decision Date | 12/17/2018 |
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| Reclassified Date | 10/20/2025 |
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| Product Code |
LOM |
| Advisory Committee |
Microbiology |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for an additional manufacturing site located at NPA de México S.A. de C.V. dba Nypro, at Sor Juana Ines de la Cruz #20150, Parque Industrial Chilpancingo, 22509 Tijuana, Baja California, Mexico, limited to manufacturing of the Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System. |
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