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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antib; PATHWAY HER-2 4 in 1 Control Slides
Classification Name: SYSTEM, TEST, HER-2/NEU, IHC
Product Code: MVC
Device Class: 3
Registered Establishment Name: VENTANA MEDICAL SYSTEMS, INC.
Registered Establishment Number: 2028492
Owner/Operator: Ventana Medical Systems, Inc/ Boone
Owner/Operator Number: 9004910
Establishment Operations: Manufacturer