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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Artisan┬┐ Iron Stain Kit
Classification Name: IRON STAINS
Product Code: GGH
Device Class: 1
Regulation Number: 864.1850
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