Product code PDY

Device name

Organophosphate Test System

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3652

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset