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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: DIRUI FUS-3000Plus Urinalysis Hybrid, DIRUI FUS-2000 Urinalysis Hybrid, DIRUI FUS-1000 Urinalysis Hybrid,; DIRUI URINE ANALYZER, DIRUI MUS-3600 Urinalysis System,DIRUI H-1600 Urine Analyzer, DIRUI HC-300 Urine Analyzer,; DIRUI URINE ANALYZER, DIRUI, Dirui H11, Dirui H10, Dirui H8, DIRUI MUS-3600 Urinalysis System
Classification Name: AUTOMATED URINALYSIS SYSTEM
Product Code: KQO
Device Class: 1
Regulation Number: 862.2900
Medical Specialty: Clinical Chemistry
Registered Establishment Name: DIRUI INDUSTRIAL CO., LTD.
Registered Establishment Number: 3003741796
Owner/Operator: DIRUI INDUSTRIAL CO., LTD.
Owner/Operator Number: 9049667
Establishment Operations: Manufacturer
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