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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ARCHITECT CEA Calibrators; ARCHITECT CEA Controls; ARCHITECT CEA Reagent Kit
Classification Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Product Code: DHX
Device Class: 2
Regulation Number: 866.6010
Medical Specialty: Immunology
Registered Establishment Name: ABBOTT IRELAND
Registered Establishment Number: 3008344661
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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