21 CFR 862.3200

§ 862.3200 Clinical toxicology calibrator.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.3200, § 862.3200 Clinical toxicology calibrator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89252
Permanent ID: ys:prov:89252@1
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Full text

(a) Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.) (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.