FDA product code PDY

Organophosphate Test System

Clinical Toxicology·Class 2·21 CFR 862.3652
US regulatory classifications
US Product Code (FDA)
PDY
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.3652
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Medical specialty
Clinical Toxicology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Organophosphate Test System is a medical device type in the Clinical Toxicology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.