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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Alinity i AFP Calibrators (LN 07P9001); Alinity i AFP Controls (LN 07P9010); Alinity i AFP Reagent Kit (LN 07P9020, 07P9030); ARCHITECT AFP Calibrators (LN 3P36-01); ARCHITECT AFP Controls (LN 3P36-10); ARCHITECT AFP Reagent Kit (LN 3P36-25, 3P36-35)
Classification Name: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Product Code: LOK
Device Class: 3
Registered Establishment Name: ABBOTT GmbH
Registered Establishment Number: 3002809144
Premarket Submission Number: P120008
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Foreign Exporter
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