Organophosphate Test System

PDY · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3652

Classification

FDA Product Code: PDY
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3652
Review panel: TX
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

For the quantitation of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device is intended to aid in the confirmation and investigation of organophosphate exposure.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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