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 411 |
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 | P110031 |
Supplement Number | S004 |
Date Received | 02/02/2012 |
Decision Date | 02/27/2012 |
Product Code |
LOM |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE IN- PROCESS PARTICLE CONCENTRATION DETERMINATION METHOD FOR THE INTERMEDIATE STORAGE FORM (ISF) BULK COMPONENT COMMON TO ALL DEVICES. |
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