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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ARCHITECT HAVAB-B Reagent Kit; ARCHITECT HAVAB-G; ARCHITECT HAVAB-G Calibrator; ARCHITECT HAVAB-G Controls
Classification Name: HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
Product Code: LOL
Device Class: 2
Regulation Number: 866.3310
Medical Specialty: Microbiology
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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