Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
Medical specialty
Microbiology
Device class
2
Regulation number
866.3367
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.