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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: MOL2200 - Simplexa CMV; MOL2210 - Simplexa CMV Quantitation Standards
Classification Name: CYTOMEGALOVIRUS (CMV) DNA QUANTITATIVE ASSAY
Product Code: PAB
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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