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U.S. Department of Health and Human Services

Product Classification

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Device enzyme immunoassay, digoxin
Regulation Description Digoxin test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeKXT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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