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U.S. Department of Health and Human Services

Product Classification

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Device system, test, radioallergosorbent (rast) immunological
Regulation Description Radioallergosorbent (RAST) immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDHB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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