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U.S. Department of Health and Human Services

Product Classification

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Device elisa, antibody, west nile virus
Regulation Description West Nile virus serological reagents.
Definition The west nile virus elisa is intended for the detection of igg and igm antibodies to west nile virus.Specimens may be serum or cerebral spinal fluid from symptomatic patients.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNOP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3940
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible