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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ELECSYS TOTAL PSA PRODUCTS
Classification Name: TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
Product Code: MTF
Device Class: 3
Registered Establishment Name: ROCHE DIAGNOSTICS GMBH
Registered Establishment Number: 9610529
Owner/Operator: Roche Diagnostics GmbH
Owner/Operator Number: 9036646
Establishment Operations: Manufacturer
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