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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLGC
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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