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U.S. Department of Health and Human Services

Product Classification

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Device antigens, indirect hemagglutination (iha) herpes simplex virus
Regulation Description Herpes simplex virus serological assays.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLKC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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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