|
Device | ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER) |
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 | P110025 |
Supplement Number | S010 |
Date Received | 07/19/2013 |
Decision Date | 08/06/2013 |
Product Code |
LOM |
Advisory Committee |
Immunology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE SPECIFICATION FOR IN-PROCESS TESTING OF A BULK REAGENT. |