# Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
> **Product code: PYN** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3367
## Classification
- **FDA Product Code:** PYN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3367
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PYN)
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