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U.S. Department of Health and Human Services

Product Classification

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Device complement c3b activator immunoassay reagents
Regulation Description Complement C3b inactivator immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeKTP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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