PYN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3367
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit (DEN160025) | Id-Fish Technology, Inc. | 2017-08-18 |
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Every clearance here is in the API, with alerts when new ones post.