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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodePYN
Regulation Number 866.3367
Device Class 2

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