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U.S. Department of Health and Human Services

Product Classification

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Device antisera, neutralization, herpesvirus hominis
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGQM
Premarket Review Division of Microbiology Devices (DMD)
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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