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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: PATHWAY Anti-c-KIT (9.7) Primary Antibody
Classification Name: IMMUNOHISTOCHEMISTRY ANTIBODY ASSAY, C-KIT
Product Code: NKF
Device Class: 3
Regulation Number: 864.1860
Medical Specialty: Hematology
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
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