§862.2. Regulation of calibrators. — Inbound Citations
21 C.F.R. § 862.2
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 862.2 as a whole
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(a) A 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. (See also § 862.2 in this part.)
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(a) 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.)