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U.S. Department of Health and Human Services

Product Classification

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Device iga, peroxidase, antigen, antiserum, control
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeCZL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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