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U.S. Department of Health and Human Services

Product Classification

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Device ige, antigen, antiserum, control
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDGC
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons
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