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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Total Prostate Specfic Antigen Imm
Classification Name: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
Product Code: MTF
Device Class: 3
Registered Establishment Name: BIOMERIEUX SA
Registered Establishment Number: 8020790
Owner/Operator: BIOMERIEUX SA
Owner/Operator Number: 8020790
Establishment Operations: Manufacturer
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