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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: THxID BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR Instrument
Classification Name: SOMATIC GENE MUTATION DETECTION SYSTEM
Product Code: OWD
Device Class: 3
Registered Establishment Name: BIOMERIEUX SA - Grenoble
Registered Establishment Number: 3008249922
Owner/Operator: BIOMERIEUX SA
Owner/Operator Number: 8020790
Establishment Operations: Manufacturer
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