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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: GeneSearch Breast Lymph Node Assay
Classification Name: RT-PCR MULTIGENE EXPRESSION TEST, SENTINEL LYMPH NODE, CANCER METASTASIS DETECTION
Product Code: OCB
Device Class: 3
Registered Establishment Name: Janssen Diagnostics, LLC
Registered Establishment Number: 3004619490
Owner/Operator: Janssen Diagnostics, LLC
Owner/Operator Number: 10023803
Establishment Operations: Manufacturer
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