PYN · Class II · 21 CFR 866.3367

FDA Product Code PYN: Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

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.

Leading manufacturers include Id-Fish Technology, Inc..

1
Total
0
Cleared
417d
Avg days
2017
Since

FDA 510(k) Cleared Fish (fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. Devices (Product Code PYN)

1 devices
1–1 of 1
Not Cleared Aug 18, 2017
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
DEN160025
Id-Fish Technology, Inc.
Microbiology · 417d

About Product Code PYN - Regulatory Context