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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ARCHITECT System; ARCHITECT System Accessories
Classification Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Product Code: JJE
Device Class: 1
Regulation Number: 862.2160
Medical Specialty: Clinical Chemistry
Registered Establishment Name: ABBOTT IRELAND
Registered Establishment Number: 3008344661
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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