21 CFR 862.3200 - Clinical toxicology calibrator.

§ 862.3200 Clinical toxicology calibrator.

(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.

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