21 CFR 862.3652
§ 862.3652 Organophosphate test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.3652, § 862.3652 Organophosphate test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89280
- Permanent ID
ys:prov:89280@1- SHA-256
4205d03e1e7ff63d5adea9228b673140e5f69a37029e74754f1477b2da714420
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. An organophosphate test system is a device intended to measure organophosphate metabolites quantitatively 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.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The distribution of these devices is limited to laboratories with experienced personnel who are trained to measure and evaluate organophosphate exposure and guide public health response.
(2) Analytical testing must demonstrate the device has appropriate performance characteristics, including adequate precision and accuracy across the measuring range and near medical decision points.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.