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U.S. Department of Health and Human Services

Product Classification
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Device antiserum, fluorescent, rabies virus
Regulation Description Rabiesvirus immunofluorescent reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGOI
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3460
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 Not Third Party Eligible
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