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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ARCHITECT Total PSA Calibrators; ARCHITECT Total PSA Controls; ARCHITECT Total PSA Reagent Kit
Classification Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Product Code: LTJ
Device Class: 2
Regulation Number: 866.6010
Medical Specialty: Immunology
Registered Establishment Name: ABBOTT GmbH & Co. KG
Registered Establishment Number: 3002809144
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Foreign Exporter
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