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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Reaction Tube for Immulite
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: Carclo Technical Plastics - Tucson
Registered Establishment Number: 3005203111
Owner/Operator: CARCLO TECHNICAL PLASTICS
Owner/Operator Number: 9020456
Establishment Operations: Contract Manufacturer
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