Product Code: PYN FDA class 2 21 CFR 866.3367

Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Microbiology

The FISH (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. is an in vitro diagnostic test intended to detect Plasmodium spp. parasites and differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection. It is classified as a Class 2 device under regulation 866.3367, meaning it requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device before marketing. The product code is PYN, and it falls within the Microbiology (MI) medical specialty. It is not an implant and is not life-sustaining.

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Basic Information

Product Code: PYN
Device Class: FDA class 2
Regulation Number: 866.3367
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

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.