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 | ELECSYS ANTI-HBC IGM ON COBAS E 601 |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD P.O. BOX 50416 INDIANAPOLIS, IN 46250-0457 |
PMA Number | P110022 |
Supplement Number | S013 |
Date Received | 10/16/2014 |
Decision Date | 11/26/2014 |
Product Code |
LOM |
Advisory Committee |
Immunology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE UPDATES OF THE US SPECIFIC E-BARCODE FOR THE COBAS E 601 AND THE US SPECIFIC ASSAY BARCODE TRANSFER SHEET FOR THE MODULAR ANALYTICS E170 TO IMPLEMENT THE GREY-ZONE. |
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