PYN — Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. Class II
FDA product code PYN covers "Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.", a Class II medical device regulated under 21 CFR 866.3367. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PYN
- Device Class
- Class II
- Regulation Number
- 866.3367
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN160025 | Id-Fish Technology | ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Co | Aug 18, 2017 |