PDY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Organophosphate Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3652
- Medical specialty
- Clinical Toxicology
- FDA 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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| Record | Firm | Date | Builder |
|---|---|---|---|
| QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS (DEN130005) | Centers for Disease Control and Prevention | 2013-08-08 |
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