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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ARCHITECT ANTI HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL; ARCHITECT ANTI-HCV REAGENT KIT
Classification Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
Product Code: MZO
Device Class: 3
Registered Establishment Name: ABBOTT GmbH & Co. KG
Registered Establishment Number: 3002809144
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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