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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: EGFR pharmDx¿ Kit for Manual Use; EGFR pharmDx¿ Kit for the Dako Autostainer
Classification Name: IMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY, EPIDERMAL GROWTH FACTOR RECEPTOR
Product Code: NQF
Device Class: 3
Regulation Number: 864.1860
Medical Specialty: Hematology
Registered Establishment Name: DAKO NORTH AMERICA, INC.
Registered Establishment Number: 2022180
Owner/Operator: DAKO A/S
Owner/Operator Number: 9004789
Establishment Operations: Manufacturer
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