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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: INFORM HER2 Dual ISH DNA Probe Cocktail
Classification Name: CHROMOGENIC IN SITU HYBRIDISATION, NUCLEIC ACID AMPLIFICATION, HER2/NEU GENE, BREAST CANCER
Product Code: NYQ
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
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