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U.S. Department of Health and Human Services

Product Classification

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Device alpha-1-antitrypsin, rhodamine, antigen, antiserum, control
Regulation Description Alpha-1-antitrypsin immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDFB
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5130
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
Third Party Review
Accredited Persons
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