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U.S. Department of Health and Human Services

Product Classification

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Device complement c1 inhibitor (inactivator), antigen, antiserum, control
Regulation Description Complement C2inhibitor (inactivator) immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDBA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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