PDY

Organophosphate Test System

Product code

PDY

Device name

Organophosphate Test System

Device class

Class 2

21 CFR

21 CFR 862.3652

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).