DeviceClearance

Product code PYN— Microbiology

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

Classification name
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
Device class
Class 2
Regulation
21 CFR 866.3367
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PYN under 21 CFR 866.3367, via openFDA

Market context for product code PYN

FDA has cleared 1 device under product code PYN, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PYN

Recent clearances under product code PYN

Data sourced from openFDA. This site is unofficial and independent of the FDA.