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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: SOMATIC GENE MUTATION DETECTION SYSTEM
Product Code: OWD
Device Class: 3
Registered Establishment Name: ROCHE MOLECULAR SYSTEMS, INC.
Registered Establishment Number: 3004141078
Owner/Operator: ROCHE MOLECULAR SYSTEMS, INC.
Owner/Operator Number: 2243471
Establishment Operations: Specification Developer
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