Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown