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U.S. Department of Health and Human Services

Product Classification
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Device antigen, cf (including cf control), herpesvirus hominis 1,2
Regulation Description Herpes simplex virus serological assays.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGQN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3305
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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