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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunosorbent assay, herpes simplex virus, hsv-1
Regulation Description Herpes simplex virus serological assays.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeMXJ
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
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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