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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: cobas e-ELECSYS FREE PSA GEN.2; Elecsys free PSA; Elecsys free PSA Test System; free PSA CalCheck; free PSA CalSet; Free PSA CC 3 Elecsys; free PSA CS Elecsys V2; free PSA CS Elecsys V3; free PSA Elecsys cobas e 100 V2; free PSA Elecsys cobas e 100 V3; free PSA Elecsys E2G 100 V2; free PSA Elecsys E2G 300; free PSA Elecsys E2G 300 V2; free PSA Gen.2 Elecsys,cobas e
Classification Name: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Product Code: LTJ
Device Class: 2
Regulation Number: 866.6010
Medical Specialty: Immunology
Registered Establishment Name: ROCHE DIAGNOSTICS GMBH
Registered Establishment Number: 9610126
Premarket Submission Number: P000027
Owner/Operator: Roche Diagnostics Operations Inc.
Owner/Operator Number: 9039767
Establishment Operations: Manufacturer
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