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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: EL0100M - Parvovirus B19 DxSelect IgM Kit
Classification Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM
Product Code: MYM
Device Class: 3
Registered Establishment Name: FOCUS DIAGNOSTICS, INC.
Registered Establishment Number: 2023365
Owner/Operator: FOCUS DIAGNOSTICS, INC.
Owner/Operator Number: 9089763
Establishment Operations: U.S. Manufacturer of Export Only Devices
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