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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PROGENSA® PCA3 Assay
Classification Name: PROSTRATE CANCER GENES NUCLEIC ACID AMPLIFICATION TEST SYSTEM
Product Code: OYM
Device Class: 3
Registered Establishment Name: GEN-PROBE INCORPORATED
Registered Establishment Number: 2024800
Owner/Operator: HOLOGIC, INC.
Owner/Operator Number: 9007676
Establishment Operations: Manufacturer
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