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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: QUANTIFERON-TB GOLD
Classification Name: TEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
Product Code: NCD
Device Class: 3
Registered Establishment Name: SCANTIBODIES LABORATORY, INC.
Registered Establishment Number: 2020808
Owner/Operator: SCANTIBODIES LABORATORY, INC.
Owner/Operator Number: 2020808
Establishment Operations: Contract Manufacturer; Manufacturer; Repackager/Relabeler
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