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-HBe Reagent Pack and Calibrator |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P100001 |
Supplement Number | S014 |
Date Received | 02/21/2018 |
Decision Date | 07/02/2018 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an additional contract 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 5600 Immunodiagnostic System. |
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