FDA product code PYN: Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
PYN is the FDA product code for fish (fluorescence in situ hybridization) kit, nucleic acid, plasmodium sp.. It is a Class II device, regulated under 21 CFR 866.3367 and reviewed by the Microbiology panel. Devices under PYN reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3367 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for PYN devices
openFDA lists no recalls for product code PYN.
Frequently asked questions
What is FDA product code PYN?
PYN is the FDA product code for fish (fluorescence in situ hybridization) kit, nucleic acid, plasmodium sp.. It is a Class II device, regulated under 21 CFR 866.3367 and reviewed by the Microbiology panel.
What device class is PYN?
Class II, regulation 21 CFR 866.3367. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PYN
- Run a recall and safety report across every PYN manufacturer
- Watch product code PYN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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