• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device fish (fluorescence in situ hybridization) kit, nucleic acid, plasmodium sp.
Definition The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection.
Physical State In vitro diagnostic devices and reagents that consist of slides, fixatives, fluorescently labeled probes, buffers, and associated instrumentation (if applicable) for the detection and identification of Plasmodium spp. parasites in clinical whole blood smear specimens.
Technical Method Fluorescence In Situ Hybridization using labeled nucleic acid probes
Target Area Target Area Clinical whole blood smear specimens from patients suspected of infection with Plasmodium spp.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePYN
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3367
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible