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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Access CEA; Access CEA Calibrators; Access CEA Diluent; Access CEA QC
Classification Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Product Code: DHX
Device Class: 2
Regulation Number: 866.6010
Medical Specialty: Immunology
Registered Establishment Name: BECKMAN COULTER, INC.
Registered Establishment Number: 2122870
Owner/Operator: BECKMAN COULTER, INC.
Owner/Operator Number: 2050012
Establishment Operations: Manufacturer; Specification Developer
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