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U.S. Department of Health and Human Services

Product Classification

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Device alpha-1-antichymotrypsin, antigen, antiserum, control
Regulation Description Alpha-1-antichymotrypsin immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDFF
Submission Type 510(k)
Regulation Number 866.5080
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons