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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: INFORM Chromosome 17 Probe; INFORM HER2 DNA Probe
Classification Name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Product Code: MVD
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: U.S. Manufacturer of Export Only Devices
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