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U.S. Department of Health and Human Services

Product Classification
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Device antisera, cf, herpesvirus hominis 1,2
Regulation Description Herpes simplex virus serological assays.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGQO
Submission Type 510(k)
Regulation Number 866.3305
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
Third Party Review Not Third Party Eligible
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