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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Analyzer
Classification Name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Product Code: LOJ
Device Class: 2
Regulation Number: 866.6010
Medical Specialty: Immunology
Registered Establishment Name: Diamond Diagnostics, Kft.
Registered Establishment Number: 3006198300
Owner/Operator: Diamond Diagnostics, Inc.
Owner/Operator Number: 10028706
Establishment Operations: Foreign Exporter
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