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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: HER2 CISH pharmDx Kit
Classification Name: CHROMOGENIC IN SITU HYBRIDISATION, NUCLEIC ACID AMPLIFICATION, HER2/NEU GENE, BREAST CANCER
Product Code: NYQ
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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