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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: HER2 FISH pharmDx? Kit; HER2 IQFISH pharmDx?
Classification Name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Product Code: MVD
Device Class: 3
Registered Establishment Name: DAKO DENMARK A/S
Registered Establishment Number: 9610099
Owner/Operator: DAKO A/S
Owner/Operator Number: 9004789
Establishment Operations: Manufacturer
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