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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BOND ORACLE HER2 IHC System
Classification Name: SYSTEM, TEST, HER-2/NEU, IHC
Product Code: MVC
Device Class: 3
Registered Establishment Name: LEICA BIOSYSTEMS NEWCASTLE LTD
Registered Establishment Number: 3004859032
Owner/Operator: Danaher Corp.
Owner/Operator Number: 8020030
Establishment Operations: Manufacturer