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U.S. Department of Health and Human Services

Product Classification

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Device radioimmunoassay (two-site solid phase), ferritin
Regulation Description Ferritin immunological test system.
Regulation Medical Specialty Immunology
Review Panel Clinical Chemistry
Product CodeJMG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5340
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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