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U.S. Department of Health and Human Services

Product Classification

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Device radioimmunoassay, digitoxin (125-i), bovine antibody, charcoal sep.
Regulation Description Digitoxin test system.
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeDPL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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