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510(k) DEN160025

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit by Id-Fish Technology, Inc. — Product Code PYN

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 18, 2017
Date Received
June 27, 2016
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
Device Class
Class II
Regulation Number
866.3367
Review Panel
MI
Submission Type

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.

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