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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ARCHITECT HBsAg Qualitative; ARCHITECT HBsAg Qualitative Confirmatory; ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent; Calibrators and Controls
Classification Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
Product Code: LOM
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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